Publications by authors named "Thomas L Bollen"

89 Publications

Auxora for the Treatment of Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome: Clinical Development of a Calcium Release-Activated Calcium Channel Inhibitor.

Pancreas 2021 Apr;50(4):537-543

CalciMedica, Inc, La Jolla, CA.

Objectives: To assess the safety of Auxora in patients with acute pancreatitis (AP), systemic inflammatory response syndrome (SIRS), and hypoxemia, and identify efficacy endpoints to prospectively test in future studies.

Methods: This phase 2, open-label, dose-response study randomized patients with AP, accompanying SIRS, and hypoxemia (n = 21) to receive low-dose or high-dose Auxora plus standard of care (SOC) or SOC alone. All patients received pancreatic contrast-enhanced computed tomography scans at screenings, day 5/discharge, and as clinically required 90 days postrandomization; scans were blinded and centrally read to determine AP severity using computed tomography severity index. Solid food tolerance was assessed at every meal and SIRS every 12 hours.

Results: The number of patients experiencing serious adverse events was not increased with Auxora versus SOC alone. Three (36.5%) patients with moderate AP receiving low-dose Auxora improved to mild AP; no computed tomography severity index improvements were observed with SOC. By study end, patients receiving Auxora better tolerated solid foods, had less persistent SIRS, and had reduced hospitalization versus SOC.

Conclusions: The favorable safety profile and patient outcomes suggest Auxora may be an appropriate early treatment for patients with AP and SIRS. Clinical development will continue in a randomized, controlled, blinded, dose-ranging study.
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http://dx.doi.org/10.1097/MPA.0000000000001793DOI Listing
April 2021

Auxora for the Treatment of Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome: Clinical Development of a Calcium Release-Activated Calcium Channel Inhibitor.

Pancreas 2021 Apr 29. Epub 2021 Apr 29.

From the Departments of Critical Care Medicine Emergency Medicine, Regions Hospital, HealthPartners, St. Paul, MN Departments of Emergency Medicine Internal Medicine, Henry Ford Hospital System Department of Emergency Medicine, Wayne State University, Detroit, MI Departments of Pulmonary Medicine Critical Care Medicine, Riverside Methodist Hospital, Columbus, OH Department of Radiology, St. Antonius Hospital, Nieuwegein, The Netherlands CalciMedica, Inc, La Jolla, CA.

Objectives: To assess the safety of Auxora in patients with acute pancreatitis (AP), systemic inflammatory response syndrome (SIRS), and hypoxemia, and identify efficacy endpoints to prospectively test in future studies.

Methods: This phase 2, open-label, dose-response study randomized patients with AP, accompanying SIRS, and hypoxemia (n = 21) to receive low-dose or high-dose Auxora plus standard of care (SOC) or SOC alone. All patients received pancreatic contrast-enhanced computed tomography scans at screenings, day 5/discharge, and as clinically required 90 days postrandomization; scans were blinded and centrally read to determine AP severity using computed tomography severity index. Solid food tolerance was assessed at every meal and SIRS every 12 hours.

Results: The number of patients experiencing serious adverse events was not increased with Auxora versus SOC alone. Three (36.5%) patients with moderate AP receiving low-dose Auxora improved to mild AP; no computed tomography severity index improvements were observed with SOC. By study end, patients receiving Auxora better tolerated solid foods, had less persistent SIRS, and had reduced hospitalization versus SOC.

Conclusions: The favorable safety profile and patient outcomes suggest Auxora may be an appropriate early treatment for patients with AP and SIRS. Clinical development will continue in a randomized, controlled, blinded, dose-ranging study.
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http://dx.doi.org/10.1097/MPA.0000000000001793DOI Listing
April 2021

Diagnosis and treatment of pancreatic duct disruption or disconnection: an international expert survey and case vignette study.

HPB (Oxford) 2021 Jan 19. Epub 2021 Jan 19.

Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands. Electronic address:

Background: Pancreatic duct disruption or disconnection is a potentially severe complication of necrotizing pancreatitis. With no existing treatment guidelines, it is unclear whether there is any consensus among experts in clinical practice. We evaluated current expert opinion regarding the diagnosis and treatment of pancreatic duct disruption and disconnection in an international case vignette study.

Methods: An online case vignette survey was sent to 110 international expert pancreatologists. Expert selection was based on publications in the last 5 years and/or participation in development of IAP/APA and ESGE guidelines on acute pancreatitis. Consensus was defined as agreement by at least 75% of the experts.

Results: The response rate was 51% (n = 56). Forty-four experts (79%) obtained a MRI/MRCP and 52 experts (93%) measured amylase levels in percutaneous drain fluid to evaluate pancreatic duct integrity. The majority of experts favored endoscopic transluminal drainage for infected (peri)pancreatic necrosis and pancreatic duct disruption (84%, n = 45) or disconnection (88%, n = 43). Consensus was lacking regarding the treatment of patients with persistent percutaneous drain production, and with persistent sterile necrosis.

Conclusion: This international survey of experts demonstrates that there are many areas for which no consensus existed, providing clear focus for future investigation.
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http://dx.doi.org/10.1016/j.hpb.2020.11.1148DOI Listing
January 2021

Treatment strategies and clinical outcomes in consecutive patients with locally advanced pancreatic cancer: A multicenter prospective cohort.

Eur J Surg Oncol 2021 Mar 26;47(3 Pt B):699-707. Epub 2020 Nov 26.

Dept. of Medical Oncology, Medical Center Leeuwarden, Leeuwarden, the Netherlands.

Introduction: Since current studies on locally advanced pancreatic cancer (LAPC) mainly report from single, high-volume centers, it is unclear if outcomes can be translated to daily clinical practice. This study provides treatment strategies and clinical outcomes within a multicenter cohort of unselected patients with LAPC.

Materials And Methods: Consecutive patients with LAPC according to Dutch Pancreatic Cancer Group criteria, were prospectively included in 14 centers from April 2015 until December 2017. A centralized expert panel reviewed response according to RECIST v1.1 and potential surgical resectability. Primary outcome was median overall survival (mOS), stratified for primary treatment strategy.

Results: Overall, 422 patients were included, of whom 77% (n = 326) received chemotherapy. The majority started with FOLFIRINOX (77%, 252/326) with a median of six cycles (IQR 4-10). Gemcitabine monotherapy was given to 13% (41/326) of patients and nab-paclitaxel/gemcitabine to 10% (33/326), with a median of two (IQR 3-5) and three (IQR 3-5) cycles respectively. The mOS of the entire cohort was 10 months (95%CI 9-11). In patients treated with FOLFIRINOX, gemcitabine monotherapy, or nab-paclitaxel/gemcitabine, mOS was 14 (95%CI 13-15), 9 (95%CI 8-10), and 9 months (95%CI 8-10), respectively. A resection was performed in 13% (32/252) of patients after FOLFIRINOX, resulting in a mOS of 23 months (95%CI 12-34).

Conclusion: This multicenter unselected cohort of patients with LAPC resulted in a 14 month mOS and a 13% resection rate after FOLFIRINOX. These data put previous results in perspective, enable us to inform patients with more accurate survival numbers and will support decision-making in clinical practice.
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http://dx.doi.org/10.1016/j.ejso.2020.11.137DOI Listing
March 2021

Pain patterns in chronic pancreatitis: a nationwide longitudinal cohort study.

Gut 2020 Nov 6. Epub 2020 Nov 6.

Department of Surgery, University Medical Centre, Utrecht, The Netherlands

Objective: Pain in chronic pancreatitis is subdivided in a continuous or intermittent pattern, each thought to represent a different entity, requiring specific treatment. Because evidence is missing, we studied pain patterns in a prospective longitudinal nationwide study.

Design: 1131 patients with chronic pancreatitis (fulfilling M-ANNHEIM criteria) were included between 2011 and 2018 in 30 Dutch hospitals. Patients with continuous or intermittent pain were compared for demographics, pain characteristics, quality of life (Short-Form 36), imaging findings, disease duration and treatment. Alternation of pain pattern and associated variables were longitudinally assessed using a multivariable multinomial logistic regression model.

Results: At inclusion, 589 patients (52%) had continuous pain, 231 patients (20%) had intermittent pain and 311 patients (28%) had no pain. Patients with continuous pain had more severe pain, used more opioids and neuropathic pain medication, and had a lower quality of life. There were no differences between pain patterns for morphological findings on imaging, disease duration and treatment. During a median follow-up of 47 months, 552 of 905 patients (61%) alternated at least once between pain patterns. All alternations were associated with the Visual Analogue Scale pain intensity score and surgery was only associated with the change from pain to no pain.

Conclusion: Continuous and intermittent pain patterns in chronic pancreatitis do not seem to be the result of distinctly different pathophysiological entities. The subjectively reported character of pain is not related to imaging findings or disease duration. Pain patterns often change over time and are merely a feature of how severity of pain is experienced.
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http://dx.doi.org/10.1136/gutjnl-2020-322117DOI Listing
November 2020

Urgent endoscopic retrograde cholangiopancreatography with sphincterotomy versus conservative treatment in predicted severe acute gallstone pancreatitis (APEC): a multicentre randomised controlled trial.

Lancet 2020 07;396(10245):167-176

Department of Gastroenterology and Hepatology, Meander Medical Center, Amersfoort, Netherlands.

Background: It remains unclear whether urgent endoscopic retrograde cholangiopancreatography (ERCP) with biliary sphincterotomy improves the outcome of patients with gallstone pancreatitis without concomitant cholangitis. We did a randomised trial to compare urgent ERCP with sphincterotomy versus conservative treatment in patients with predicted severe acute gallstone pancreatitis.

Methods: In this multicentre, parallel-group, assessor-masked, randomised controlled superiority trial, patients with predicted severe (Acute Physiology and Chronic Health Evaluation II score ≥8, Imrie score ≥3, or C-reactive protein concentration >150 mg/L) gallstone pancreatitis without cholangitis were assessed for eligibility in 26 hospitals in the Netherlands. Patients were randomly assigned (1:1) by a web-based randomisation module with randomly varying block sizes to urgent ERCP with sphincterotomy (within 24 h after hospital presentation) or conservative treatment. The primary endpoint was a composite of mortality or major complications (new-onset persistent organ failure, cholangitis, bacteraemia, pneumonia, pancreatic necrosis, or pancreatic insufficiency) within 6 months of randomisation. Analysis was by intention to treat. This trial is registered with the ISRCTN registry, ISRCTN97372133.

Findings: Between Feb 28, 2013, and March 1, 2017, 232 patients were randomly assigned to urgent ERCP with sphincterotomy (n=118) or conservative treatment (n=114). One patient from each group was excluded from the final analysis because of cholangitis (urgent ERCP group) and chronic pancreatitis (conservative treatment group) at admission. The primary endpoint occurred in 45 (38%) of 117 patients in the urgent ERCP group and in 50 (44%) of 113 patients in the conservative treatment group (risk ratio [RR] 0·87, 95% CI 0·64-1·18; p=0·37). No relevant differences in the individual components of the primary endpoint were recorded between groups, apart from the occurrence of cholangitis (two [2%] of 117 in the urgent ERCP group vs 11 [10%] of 113 in the conservative treatment group; RR 0·18, 95% CI 0·04-0·78; p=0·010). Adverse events were reported in 87 (74%) of 118 patients in the urgent ERCP group versus 91 (80%) of 114 patients in the conservative treatment group.

Interpretation: In patients with predicted severe gallstone pancreatitis but without cholangitis, urgent ERCP with sphincterotomy did not reduce the composite endpoint of major complications or mortality, compared with conservative treatment. Our findings support a conservative strategy in patients with predicted severe acute gallstone pancreatitis with an ERCP indicated only in patients with cholangitis or persistent cholestasis.

Funding: The Netherlands Organization for Health Research and Development, Fonds NutsOhra, and the Dutch Patient Organization for Pancreatic Diseases.
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http://dx.doi.org/10.1016/S0140-6736(20)30539-0DOI Listing
July 2020

Various Modalities Accurate in Diagnosing a Disrupted or Disconnected Pancreatic Duct in Acute Pancreatitis: A Systematic Review.

Dig Dis Sci 2021 May 27;66(5):1415-1424. Epub 2020 Jun 27.

Department of Surgery, St. Antonius Hospital, PO 2500, 3430 EM, Nieuwegein, The Netherlands.

Background: Severe pancreatitis may result in a disrupted pancreatic duct, which is associated with a complicated clinical course. Diagnosis of a disrupted pancreatic duct is not standardized in clinical practice or international guidelines. We performed a systematic review of the literature on imaging modalities for diagnosing a disrupted pancreatic duct in patients with acute pancreatitis.

Methods: A systematic search was performed in PubMed, Embase and Cochrane library databases to identify all studies evaluating diagnostic modalities for the diagnosis of a disrupted pancreatic duct in acute pancreatitis. All data regarding diagnostic accuracy were extracted.

Results: We included 8 studies, evaluating five different diagnostic modalities in 142 patients with severe acute pancreatitis. Study quality was assessed, with proportionally divided high and low risk of bias and low applicability concerns in 75% of the studies. A sensitivity of 100% was reported for endoscopic ultrasound and endoscopic retrograde cholangiopancreatography. The sensitivity of magnetic resonance cholangiopancreatography with or without secretin was 83%. A sensitivity of 92% was demonstrated for a combined cohort of secretin-magnetic resonance cholangiopancreatography and magnetic resonance cholangiopancreatography. A sensitivity of 100% and specificity of 50% was found for amylase measurements in drain fluid compared with ERCP.

Conclusions: This review suggests that various diagnostic modalities are accurate in diagnosing a disrupted pancreatic duct in patients with acute pancreatitis. Amylase measurement in drain fluid should be standardized. Given the invasive nature of other modalities, secretin-magnetic resonance cholangiopancreatography or magnetic resonance cholangiopancreatography would be recommended as first diagnostic modality. Further prospective studies, however, are needed.
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http://dx.doi.org/10.1007/s10620-020-06413-0DOI Listing
May 2021

Care after pancreatic resection according to an algorithm for early detection and minimally invasive management of pancreatic fistula versus current practice (PORSCH-trial): design and rationale of a nationwide stepped-wedge cluster-randomized trial.

Trials 2020 May 7;21(1):389. Epub 2020 May 7.

Department of Surgery, Regional Academic Cancer Center Utrecht, St. Antonius Hospital and University Medical Center Utrecht, PO Box 85500, Utrecht, 3508, GA, The Netherlands.

Background: Pancreatic resection is a major abdominal operation with 50% risk of postoperative complications. A common complication is pancreatic fistula, which may have severe clinical consequences such as postoperative bleeding, organ failure and death. The objective of this study is to investigate whether implementation of an algorithm for early detection and minimally invasive management of pancreatic fistula may improve outcomes after pancreatic resection.

Methods: This is a nationwide stepped-wedge, cluster-randomized, superiority trial, designed in adherence to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. During a period of 22 months, all Dutch centers performing pancreatic surgery will cross over in a randomized order from current practice to best practice according to the algorithm. This evidence-based and consensus-based algorithm will provide daily multilevel advice on the management of patients after pancreatic resection (i.e. indication for abdominal imaging, antibiotic treatment, percutaneous drainage and removal of abdominal drains). The algorithm is designed to aid early detection and minimally invasive step-up management of postoperative pancreatic fistula. Outcomes of current practice will be compared with outcomes after implementation of the algorithm. The primary outcome is a composite of major complications (i.e. post-pancreatectomy bleeding, new-onset organ failure and death) and will be measured in a sample size of at least 1600 patients undergoing pancreatic resection. Secondary endpoints include the individual components of the primary endpoint and other clinical outcomes, healthcare resource utilization and costs analysis. Follow up will be up to 90 days after pancreatic resection.

Discussion: It is hypothesized that a structured nationwide implementation of a dedicated algorithm for early detection and minimally invasive step-up management of postoperative pancreatic fistula will reduce the risk of major complications and death after pancreatic resection, as compared to current practice.

Trial Registration: Netherlands Trial Register: NL 6671. Registered on 16 December 2017.
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http://dx.doi.org/10.1186/s13063-020-4167-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7206814PMC
May 2020

Effect of Early Surgery vs Endoscopy-First Approach on Pain in Patients With Chronic Pancreatitis: The ESCAPE Randomized Clinical Trial.

JAMA 2020 01;323(3):237-247

Department of Surgery, Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.

Importance: For patients with painful chronic pancreatitis, surgical treatment is postponed until medical and endoscopic treatment have failed. Observational studies have suggested that earlier surgery could mitigate disease progression, providing better pain control and preserving pancreatic function.

Objective: To determine whether early surgery is more effective than the endoscopy-first approach in terms of clinical outcomes.

Design, Setting, And Participants: The ESCAPE trial was an unblinded, multicenter, randomized clinical superiority trial involving 30 Dutch hospitals participating in the Dutch Pancreatitis Study Group. From April 2011 until September 2016, a total of 88 patients with chronic pancreatitis, a dilated main pancreatic duct, and who only recently started using prescribed opioids for severe pain (strong opioids for ≤2 months or weak opioids for ≤6 months) were included. The 18-month follow-up period ended in March 2018.

Interventions: There were 44 patients randomized to the early surgery group who underwent pancreatic drainage surgery within 6 weeks after randomization and 44 patients randomized to the endoscopy-first approach group who underwent medical treatment, endoscopy including lithotripsy if needed, and surgery if needed.

Main Outcomes And Measures: The primary outcome was pain, measured on the Izbicki pain score and integrated over 18 months (range, 0-100 [increasing score indicates more pain severity]). Secondary outcomes were pain relief at the end of follow-up; number of interventions, complications, hospital admissions; pancreatic function; quality of life (measured on the 36-Item Short Form Health Survey [SF-36]); and mortality.

Results: Among 88 patients who were randomized (mean age, 52 years; 21 (24%) women), 85 (97%) completed the trial. During 18 months of follow-up, patients in the early surgery group had a lower Izbicki pain score than patients in the group randomized to receive the endoscopy-first approach group (37 vs 49; between-group difference, -12 points [95% CI, -22 to -2]; P = .02). Complete or partial pain relief at end of follow-up was achieved in 23 of 40 patients (58%) in the early surgery vs 16 of 41 (39%)in the endoscopy-first approach group (P = .10). The total number of interventions was lower in the early surgery group (median, 1 vs 3; P < .001). Treatment complications (27% vs 25%), mortality (0% vs 0%), hospital admissions, pancreatic function, and quality of life were not significantly different between early surgery and the endoscopy-first approach.

Conclusions And Relevance: Among patients with chronic pancreatitis, early surgery compared with an endoscopy-first approach resulted in lower pain scores when integrated over 18 months. However, further research is needed to assess persistence of differences over time and to replicate the study findings.

Trial Registration: ISRCTN Identifier: ISRCTN45877994.
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http://dx.doi.org/10.1001/jama.2019.20967DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6990680PMC
January 2020

Mean muscle attenuation correlates with severe acute pancreatitis unlike visceral adipose tissue and subcutaneous adipose tissue.

United European Gastroenterol J 2019 12 9;7(10):1312-1320. Epub 2019 Oct 9.

Department of Internal Medicine I, Martin Luther University, Halle (Saale), Germany.

Background: Acute pancreatitis (AP) is a frequent disorder with considerable morbidity and mortality. Obesity has previously been reported to influence disease severity.

Objective: The aim of this study was to investigate the association of adipose and muscle parameters with the severity grade of AP.

Methods: In total 454 patients were recruited. The first contrast-enhanced computed tomography of each patient was reviewed for adipose and muscle tissue parameters at L3 level. Associations with disease severity were analysed through logistic regression analysis. The predictive capacity of the parameters was investigated using receiver operating characteristic (ROC) curves.

Results: No distinct variation was found between the AP severity groups in either adipose tissue parameters (visceral adipose tissue and subcutaneous adipose tissue) or visceral muscle ratio. However, muscle mass and mean muscle attenuation differed significantly with -values of 0.037 and 0.003 respectively. In multivariate analysis, low muscle attenuation was associated with severe AP with an odds ratio of 4.09 (95% confidence intervals: 1.61-10.36, -value 0.003). No body parameter presented sufficient predictive capability in ROC-curve analysis.

Conclusions: Our results demonstrate that a low muscle attenuation level is associated with an increased risk of severe AP. Future prospective studies will help identify the underlying mechanisms and characterise the influence of body composition parameters on AP.
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http://dx.doi.org/10.1177/2050640619882520DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6893994PMC
December 2019

Postponed or immediate drainage of infected necrotizing pancreatitis (POINTER trial): study protocol for a randomized controlled trial.

Trials 2019 Apr 25;20(1):239. Epub 2019 Apr 25.

Department of Gastroenterology and Hepatology, Albert Schweitzer Hospital Dordrecht, Dordrecht, Netherlands.

Background: Infected necrosis complicates 10% of all acute pancreatitis episodes and is associated with 15-20% mortality. The current standard treatment for infected necrotizing pancreatitis is the step-up approach (catheter drainage, followed, if necessary, by minimally invasive necrosectomy). Catheter drainage is preferably postponed until the stage of walled-off necrosis, which usually takes 4 weeks. This delay stems from the time when open necrosectomy was the standard. It is unclear whether such delay is needed for catheter drainage or whether earlier intervention could actually be beneficial in the current step-up approach. The POINTER trial investigates if immediate catheter drainage in patients with infected necrotizing pancreatitis is superior to the current practice of postponed intervention.

Methods: POINTER is a randomized controlled multicenter superiority trial. All patients with necrotizing pancreatitis are screened for eligibility. In total, 104 adult patients with (suspected) infected necrotizing pancreatitis will be randomized to immediate (within 24 h) catheter drainage or current standard care involving postponed catheter drainage. Necrosectomy, if necessary, is preferably postponed until the stage of walled-off necrosis, in both treatment arms. The primary outcome is the Comprehensive Complication Index (CCI), which covers all complications between randomization and 6-month follow up. Secondary outcomes include mortality, complications, number of (repeat) interventions, hospital and intensive care unit (ICU) lengths of stay, quality-adjusted life years (QALYs) and direct and indirect costs. Standard follow-up is at 3 and 6 months after randomization.

Discussion: The POINTER trial investigates if immediate catheter drainage in infected necrotizing pancreatitis reduces the composite endpoint of complications, as compared with the current standard treatment strategy involving delay of intervention until the stage of walled-off necrosis.

Trial Registration: ISRCTN, 33682933 . Registered on 6 August 2015. Retrospectively registered.
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http://dx.doi.org/10.1186/s13063-019-3315-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6482524PMC
April 2019

Predicting a 'difficult cholecystectomy' after mild gallstone pancreatitis.

HPB (Oxford) 2019 07 8;21(7):827-833. Epub 2018 Dec 8.

Department of Surgery, Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Netherlands. Electronic address:

Background: Cholecystectomy after gallstone pancreatitis may be technically demanding. The aim of this study was to investigate risk factors for a difficult cholecystectomy after mild pancreatitis.

Methods: This was a prospective study within a randomized controlled trial on the timing of cholecystectomy after mild gallstone pancreatitis. Difficulty of cholecystectomy was scored on a 0 to 10 visual analogue scale (VAS) by the senior attending surgeon. The primary outcome 'difficult cholecystectomy' was defined by presence of one or more of the following features: a VAS score ≥ 8, duration of surgery > 75 minutes, conversion or subtotal cholecystectomy.

Results: 249 patients were included in the primary analysis. A difficult cholecystectomy occurred in 82 patients (33%). In the 'same-admission cholecystectomy' group 29 of 112 cholecystectomies were difficult (26%) versus 49 of 127 patients (39%) who underwent surgery after 2 weeks (p = 0.037). After multivariable analysis, male sex (OR 1.80, 95% confidence interval [CI] 1.04-3.13; p = 0.037), prior sphincterotomy (OR 1.79, 95% CI 1.01-3.16; p = 0.046), and delaying cholecystectomy for at least two weeks (OR 1.81, 95% CI 1.04-3.16; p = 0.036) were independent predictors of a difficult cholecystectomy.

Conclusion: Surgeons should anticipate a difficult cholecystectomy after mild gallstone pancreatitis in case of male sex, prior sphincterotomy and delayed cholecystectomy.
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http://dx.doi.org/10.1016/j.hpb.2018.10.015DOI Listing
July 2019

Superiority of Step-up Approach vs Open Necrosectomy in Long-term Follow-up of Patients With Necrotizing Pancreatitis.

Gastroenterology 2019 03 2;156(4):1016-1026. Epub 2018 Nov 2.

Department of Surgery, Leiden University Medical Center, Leiden, the Netherlands.

Background & Aims: In a 2010 randomized trial (the PANTER trial), a surgical step-up approach for infected necrotizing pancreatitis was found to reduce the composite endpoint of death or major complications compared with open necrosectomy; 35% of patients were successfully treated with simple catheter drainage only. There is concern, however, that minimally invasive treatment increases the need for reinterventions for residual peripancreatic necrotic collections and other complications during the long term. We therefore performed a long-term follow-up study.

Methods: We reevaluated all the 73 patients (of the 88 patients randomly assigned to groups) who were still alive after the index admission, at a mean 86 months (±11 months) of follow-up. We collected data on all clinical and health care resource utilization endpoints through this follow-up period. The primary endpoint was death or major complications (the same as for the PANTER trial). We also measured exocrine insufficiency, quality of life (using the Short Form-36 and EuroQol 5 dimensions forms), and Izbicki pain scores.

Results: From index admission to long-term follow-up, 19 patients (44%) died or had major complications in the step-up group compared with 33 patients (73%) in the open-necrosectomy group (P = .005). Significantly lower proportions of patients in the step-up group had incisional hernias (23% vs 53%; P = .004), pancreatic exocrine insufficiency (29% vs 56%; P = .03), or endocrine insufficiency (40% vs 64%; P = .05). There were no significant differences between groups in proportions of patients requiring additional drainage procedures (11% vs 13%; P = .99) or pancreatic surgery (11% vs 5%; P = .43), or in recurrent acute pancreatitis, chronic pancreatitis, Izbicki pain scores, or medical costs. Quality of life increased during follow-up without a significant difference between groups.

Conclusions: In an analysis of long-term outcomes of trial participants, we found the step-up approach for necrotizing pancreatitis to be superior to open necrosectomy, without increased risk of reinterventions.
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http://dx.doi.org/10.1053/j.gastro.2018.10.045DOI Listing
March 2019

The lateral femoral notch sign: a reliable diagnostic measurement in acute anterior cruciate ligament injury.

Knee Surg Sports Traumatol Arthrosc 2019 Feb 13;27(2):659-664. Epub 2018 Oct 13.

Department of Orthopaedic Surgery, St. Antonius Hospital, Koekoekslaan 1, 3435 CM, Nieuwegein, The Netherlands.

Purpose: To describe the validity and inter- and intra-observer reliability of the lateral femoral notch sign (LFNS) as measured on conventional radiographs for diagnosing acute anterior cruciate ligament (ACL) injury.

Methods: Patients (≤ 45 years) with a traumatic knee injury who underwent knee arthroscopy and had preoperative radiographs were retrospectively screened for this case-control study. Included patients were assigned to the ACL injury group (n = 65) or the control group (n = 53) based on the arthroscopic findings. All radiographs were evaluated for the presence, depth and location of the LFNS by four physicians who were blind to the conditions. To calculate intra-observer reliability, each observer re-assessed 25% of the radiographs at a 4-week interval.

Results: The depth of the LFNS was significantly greater in ACL-injured patients than in controls [median 0.8 mm (0-3.1 mm) versus 0.0 mm (0-1.4 mm), respectively; p = 0.008]. The inter- and intra-observer reliabilities of the LFNS depth were 0.93 and 0.96, respectively. Secondary knee pathology (i.e., lateral meniscal injury) in ACL-injured patients was correlated with a deeper LFNS [median 1.1 mm (0-2.6 mm) versus 0.6 mm (0-3.1 mm), p = 0.012]. Using a cut-off value of 1 mm for the LFNS depth, a positive predictive value of 96% was found.

Conclusion: This was the first study to investigate the inter- and intra-observer agreement of the depth and location of the LFNS. The depth of the LFNS had a very high predictive value for ACL-injured patients and could be used in the emergency department without any additional cost. A depth of > 1.0 mm was a good predictor for ACL injury. Measuring the depth of the LFNS is a simple and clinically relevant tool for diagnosing ACL injury in the acute setting and should be used by clinicians in patients with acute knee trauma.

Level Of Evidence: Diagnostic study, level II.
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http://dx.doi.org/10.1007/s00167-018-5214-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6394542PMC
February 2019

Laparoscopic cholecystectomy versus percutaneous catheter drainage for acute cholecystitis in high risk patients (CHOCOLATE): multicentre randomised clinical trial.

BMJ 2018 Oct 8;363:k3965. Epub 2018 Oct 8.

Department of Surgery, St Antonius Hospital, 3435CM, PO box 2500, Nieuwegein, Netherlands

Objective: To assess whether laparoscopic cholecystectomy is superior to percutaneous catheter drainage in high risk patients with acute calculous cholecystitis.

Design: Multicentre, randomised controlled, superiority trial.

Setting: 11 hospitals in the Netherlands, February 2011 to January 2016.

Participants: 142 high risk patients with acute calculous cholecystitis were randomly allocated to laparoscopic cholecystectomy (n=66) or to percutaneous catheter drainage (n=68). High risk was defined as an acute physiological assessment and chronic health evaluation II (APACHE II) score of 7 or more.

Main Outcome Measures: The primary endpoints were death within one year and the occurrence of major complications, defined as infectious and cardiopulmonary complications within one month, need for reintervention (surgical, radiological, or endoscopic that had to be related to acute cholecystitis) within one year, or recurrent biliary disease within one year.

Results: The trial was concluded early after a planned interim analysis. The rate of death did not differ between the laparoscopic cholecystectomy and percutaneous catheter drainage group (3% 9%, P=0.27), but major complications occurred in eight of 66 patients (12%) assigned to cholecystectomy and in 44 of 68 patients (65%) assigned to percutaneous drainage (risk ratio 0.19, 95% confidence interval 0.10 to 0.37; P<0.001). In the drainage group 45 patients (66%) required a reintervention compared with eight patients (12%) in the cholecystectomy group (P<0.001). Recurrent biliary disease occurred more often in the percutaneous drainage group (53% 5%, P<0.001), and the median length of hospital stay was longer (9 days 5 days, P<0.001).

Conclusion: Laparoscopic cholecystectomy compared with percutaneous catheter drainage reduced the rate of major complications in high risk patients with acute cholecystitis.

Trial Registration: Dutch Trial Register NTR2666.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6174331PMC
http://dx.doi.org/10.1136/bmj.k3965DOI Listing
October 2018

Radiological Workup of Cystic Neoplasms of the Pancreas.

Visc Med 2018 Jul 15;34(3):182-190. Epub 2018 Jun 15.

Department of Radiology, University Medical Center Utrecht, Utrecht, the Netherlands.

Pancreatic cystic lesions are being detected with increasing frequency because of increased use and improved quality of cross-sectional imaging techniques. Pancreatic cystic lesions encompass non-neoplastic lesions (such as pancreatitis-related collections) and neoplastic tumors. Common cystic pancreatic neoplasms include serous cystadenomas, mucinous cystic neoplasms, intraductal papillary mucinous neoplasms, and solid pseudopapillary tumors. These cystic pancreatic neoplasms may have typical morphology, but at times show overlapping imaging features on cross-sectional examinations. This article reviews the classical and atypical imaging features of commonly encountered cystic pancreatic neoplasms and presents the limitations of current cross-sectional imaging techniques in accurately classifying pancreatic cystic lesions.
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http://dx.doi.org/10.1159/000489674DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6103340PMC
July 2018

Impact of characteristics of organ failure and infected necrosis on mortality in necrotising pancreatitis.

Gut 2019 06 27;68(6):1044-1051. Epub 2018 Jun 27.

Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.

Objective: In patients with pancreatitis, early persisting organ failure is believed to be the most important cause of mortality. This study investigates the relation between the timing (onset and duration) of organ failure and mortality and its association with infected pancreatic necrosis in patients with necrotising pancreatitis.

Design: We performed a post hoc analysis of a prospective database of 639 patients with necrotising pancreatitis from 21 hospitals. We evaluated the onset, duration and type of organ failure (ie, respiratory, cardiovascular and renal failure) and its association with mortality and infected pancreatic necrosis.

Results: In total, 240 of 639 (38%) patients with necrotising pancreatitis developed organ failure. Persistent organ failure (ie, any type or combination) started in the first week in 51% of patients with 42% mortality, in 13% during the second week with 46% mortality and in 36% after the second week with 29% mortality. Mortality in patients with persistent multiple organ failure lasting <1 week, 1-2 weeks, 2-3 weeks or longer than 3 weeks was 43%, 38%, 46% and 52%, respectively (p=0.68). Mortality was higher in patients with organ failure alone than in patients with organ failure and infected pancreatic necrosis (44% vs 29%, p=0.04). However, when excluding patients with very early mortality (within 10 days of admission), patients with organ failure with or without infected pancreatic necrosis had similar mortality rates (28% vs 34%, p=0.33).

Conclusion: In patients with necrotising pancreatitis, early persistent organ failure is not associated with increased mortality when compared with persistent organ failure which develops further on during the disease course. Furthermore, no association was found between the duration of organ failure and mortality.
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http://dx.doi.org/10.1136/gutjnl-2017-314657DOI Listing
June 2019

Natural History of Gas Configurations and Encapsulation in Necrotic Collections During Necrotizing Pancreatitis.

J Gastrointest Surg 2018 09 11;22(9):1557-1564. Epub 2018 May 11.

Department of Radiology, St. Antonius Hospital, PO Box 2500, 3430 EM, Nieuwegein, the Netherlands.

Background: Decision-making on invasive intervention in patients with clinical signs of infected necrotizing pancreatitis is often related to the presence of gas configurations and the degree of encapsulation in necrotic collections on imaging. Data on the natural history of gas configurations and encapsulation in necrotizing pancreatitis are, however, lacking.

Methods: A post hoc analysis was performed of a previously described prospective cohort in 21 Dutch hospitals (2004-2008). All computed tomography scans (CTs) performed during hospitalization for necrotizing pancreatitis were categorized per week (1 to 8, and thereafter) and re-assessed by an abdominal radiologist.

Results: A total of 639 patients with necrotizing pancreatitis were included, with median four (IQR 2-7) CTs per patient. The incidence of first onset of gas configurations varied per week without a linear correlation: 2-3-13-11-10-19-12-21-12%, respectively. Overall, gas configurations were found in 113/639 (18%) patients and in 113/202 (56%) patients with infected necrosis. The incidence of walled-off necrosis increased per week: 0-3-12-39-62-76-93-97-100% for weeks 1-8 and thereafter respectively. Clinically relevant walled-off necrosis (largely or fully encapsulated necrotic collections) was seen in 162/379 (43%) patients within the first 3 weeks.

Conclusions: Gas configurations occur in every phase of the disease and develop in half of the patients with infected necrotizing pancreatitis. Opposed to traditional views, clinically relevant walled-off necrosis occurs frequently within the first 3 weeks.
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http://dx.doi.org/10.1007/s11605-018-3792-zDOI Listing
September 2018

MR imaging of hemorrhage associated with acute pancreatitis.

Pancreatology 2018 Jun 27;18(4):363-369. Epub 2018 Mar 27.

Sichuan Key Laboratory of Medical Imaging, Department of Radiology, Affiliated Hospital of North Sichuan Medical College, Wenhua Road 63, Nanchong 637000, Sichuan, PR China. Electronic address:

Purpose: To study MRI findings of hemorrhage in acute pancreatitis (AP) and correlate the presence and extent of hemorrhage with the MR severity index (MRSI), Acute Physiology And Chronic Health Evaluation (APACHE) II scores, and clinical outcome.

Materials And Methods: This retrospective study included 539 patients with AP. Hemorrhage was defined as areas of hyperintensity in or outside the pancreas on liver imaging with volume acceleration flexible (LAVA-Flex). The presence of hemorrhage was classified into three areas: within the pancreatic parenchyma, retroperitoneal space, and sub-or intraperitoneal space. Involvement of each area was awarded 1 point resulting in the hemorrhage severity index (HSI) score. The predicted severity of AP was graded by MRSI and APACHE II score. The association between HSI, MRSI, and APACHE II scores was analyzed. The length of hospital stay and organ dysfunction was used as clinical outcome parameters.

Results: Among 539 AP patients, 62 (11.5%) had hemorrhage. The prevalence of hemorrhage was 1.1% (2/186), 13.9% (43/310), and 39.5% (17/43) in predicted mild, moderate, and severe AP, respectively, based on MRSI (χ = 55.3, p = 0.00); and 7.7% (21/273) and 19.2% (18/94) in predicted mild and severe AP, respectively, based on APACHE II (χ = 21.2, p = 0.00). HSI score significantly correlated with MRSI (r = 0.36, p < 0.001) and APACHE II scores (r = 0.21, p = 0.00). The prevalence of organ dysfunction was higher and length of hospital stay was longer in patients with hemorrhage than in those without hemorrhage (p < 0.01).

Conclusions: Hemorrhage in AP is common. The presence of hemorrhage, rather than its extent, correlates with poor clinical outcome.
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http://dx.doi.org/10.1016/j.pan.2018.03.004DOI Listing
June 2018

Comparison of MRI and colonoscopy in determining tumor height in rectal cancer.

United European Gastroenterol J 2018 Feb 21;6(1):131-137. Epub 2017 Apr 21.

Department of Gastroenterology and Hepatology, St Antonius Hospital Nieuwegein, The Netherlands.

Background And Aim: Endoscopy and magnetic resonance imaging (MRI) are used routinely in the diagnostic and preoperative work-up of rectal cancer. We aimed to compare colonoscopy and MRI in determining rectal tumor height.

Methods: Between 2002 and 2012, all patients with rectal cancer with available MRIs and endoscopy reports were included. All MRIs were reassessed for tumor height by two abdominal radiologists. To obtain insight in techniques used for endoscopic determination of tumor height, a survey among regional endoscopists was conducted.

Results: A total of 211 patients with rectal cancer were included. Tumor height was significantly lower when assessed by MRI than by endoscopy with a mean difference of 2.5 cm (95% CI: 2.1-2.8). Although the agreement between tumor height as measured by MRI and endoscopy was good (intraclass correlation coefficient (ICC) 0.7 (95% CI: 0.7-0.8)), the 95% limits of agreement varied from -3.0 cm to 8.0 cm. In 45 patients (21.3%), tumors were regarded as low by MRI and middle-high by endoscopy. MRI inter- and intraobserver agreements were excellent with an ICC of 0.8 (95% CI: 0.7-0.9) and 0.9 (95% CI: 0.9-1.0), respectively. The survey showed no consensus among endoscopists as to how to technically measure tumor height.

Conclusion: This study showed large variability in rectal tumor height as measured by colonoscopy and MRI. Since MRI measurements showed excellent inter- and intraobserver agreement, we suggest using tumor height measurement by MRI for diagnostic purposes and treatment allocation.
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http://dx.doi.org/10.1177/2050640617707090DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5802669PMC
February 2018

Short article: Presence, extent and location of pancreatic necrosis are independent of aetiology in acute pancreatitis.

Eur J Gastroenterol Hepatol 2018 03;30(3):342-345

Radiology, St Antonius Hospital, Nieuwegein, The Netherlands.

Objective: The most common aetiologies of acute pancreatitis (AP) are gallstones, alcohol and idiopathic. The impact of the aetiology of AP on the extent and morphology of pancreatic and extrapancreatic necrosis (EXPN) has not been clearly established. The aim of the present study was to assess the influence of aetiology on the presence and location of pancreatic necrosis in patients with AP.

Patients And Methods: We carried out a post-hoc analysis of a previously established multicentre cohort of patients with AP in whom a computed tomography was available for review. Clinical data were obtained from the medical records. All computed tomographies were revised by the same expert radiologist. The impact of aetiology on pancreatic and EXPN was calculated.

Results: In total, 159 patients with necrotizing pancreatitis were identified from a cohort of 285 patients. The most frequent aetiologies were biliary (105 patients, 37%), followed by alcohol (102 patients, 36%) and other aetiologies including idiopathic (78 patients, 27%). No relationship was found between the aetiology and the presence of pancreatic necrosis, EXPN, location of pancreatic necrosis or presence of collections.

Conclusion: We found no association between the aetiology of AP and the presence, extent and anatomical location of pancreatic necrosis.
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http://dx.doi.org/10.1097/MEG.0000000000001053DOI Listing
March 2018

Endoscopic or surgical step-up approach for infected necrotising pancreatitis: a multicentre randomised trial.

Lancet 2018 01 3;391(10115):51-58. Epub 2017 Nov 3.

Department of Surgery, Reinier de Graaf Group, Delft, Netherlands.

Background: Infected necrotising pancreatitis is a potentially lethal disease and an indication for invasive intervention. The surgical step-up approach is the standard treatment. A promising alternative is the endoscopic step-up approach. We compared both approaches to see whether the endoscopic step-up approach was superior to the surgical step-up approach in terms of clinical and economic outcomes.

Methods: In this multicentre, randomised, superiority trial, we recruited adult patients with infected necrotising pancreatitis and an indication for invasive intervention from 19 hospitals in the Netherlands. Patients were randomly assigned to either the endoscopic or the surgical step-up approach. The endoscopic approach consisted of endoscopic ultrasound-guided transluminal drainage followed, if necessary, by endoscopic necrosectomy. The surgical approach consisted of percutaneous catheter drainage followed, if necessary, by video-assisted retroperitoneal debridement. The primary endpoint was a composite of major complications or death during 6-month follow-up. Analyses were by intention to treat. This trial is registered with the ISRCTN registry, number ISRCTN09186711.

Findings: Between Sept 20, 2011, and Jan 29, 2015, we screened 418 patients with pancreatic or extrapancreatic necrosis, of which 98 patients were enrolled and randomly assigned to the endoscopic step-up approach (n=51) or the surgical step-up approach (n=47). The primary endpoint occurred in 22 (43%) of 51 patients in the endoscopy group and in 21 (45%) of 47 patients in the surgery group (risk ratio [RR] 0·97, 95% CI 0·62-1·51; p=0·88). Mortality did not differ between groups (nine [18%] patients in the endoscopy group vs six [13%] patients in the surgery group; RR 1·38, 95% CI 0·53-3·59, p=0·50), nor did any of the major complications included in the primary endpoint.

Interpretation: In patients with infected necrotising pancreatitis, the endoscopic step-up approach was not superior to the surgical step-up approach in reducing major complications or death. The rate of pancreatic fistulas and length of hospital stay were lower in the endoscopy group. The outcome of this trial will probably result in a shift to the endoscopic step-up approach as treatment preference.

Funding: The Dutch Digestive Disease Foundation, Fonds NutsOhra, and the Netherlands Organization for Health Research and Development.
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http://dx.doi.org/10.1016/S0140-6736(17)32404-2DOI Listing
January 2018

Early Abdominal Imaging Remains Over-Utilized in Acute Pancreatitis.

Dig Dis Sci 2017 10 24;62(10):2894-2899. Epub 2017 Aug 24.

Division of Gastroenterology, Pancreatitis Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

Background: Early abdominal computed tomography (CT) or magnetic resonance (MR) imaging is common in acute pancreatitis (AP). Guidelines (2007-2013) indicate routine use is unwarranted.

Aims: To compare the frequency and evaluate the predictors of early CT/MR utilization for AP between September 2006-2007 (period A) and September 2014-2015 (period B).

Methods: AP patients presenting directly to a large academic emergency department were prospectively enrolled during each period. Cases requiring imaging to fulfill diagnostic criteria were excluded. Early CT/MR (within 24 h of presentation) utilization rates were compared using Fisher's exact test. Predictors of early imaging usage were assessed with multivariate logistic regression.

Results: The cohort included 96 AP cases in period A and 97 in period B. There were no significant differences in patient demographics, comorbidity scores, or AP severity. Period B cases manifested decreased rates of the systemic inflammatory response syndrome (SIRS) during the first 24 h of hospitalization (67% period A vs. 43% period B, p = 0.001). Independent predictors of early imaging included age >60 and SIRS or organ failure on day 1. No significant decrease in early CT/MR usage was observed from period A to B on both univariate (49% period A vs. 40% period B, p = 0.25) and multivariate (OR 1.0 for period B vs. A, 95% CI 0.5-1.9) analysis.

Conclusions: In a comparison of imaging practices for AP, there was no significant decrease in early abdominal CT/MR utilization from 2007 to 2015. Quality improvement initiatives specifically targeting early imaging overuse are needed.
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http://dx.doi.org/10.1007/s10620-017-4720-xDOI Listing
October 2017

Diagnosis and treatment in chronic pancreatitis: an international survey and case vignette study.

HPB (Oxford) 2017 11 15;19(11):978-985. Epub 2017 Aug 15.

Department of Surgery, Academic Medical Center, Amsterdam, The Netherlands.

Background: The aim of the study was to evaluate the current opinion and clinical decision-making process of international pancreatologists, and to systematically identify key study questions regarding the diagnosis and treatment of chronic pancreatitis (CP) for future research.

Methods: An online survey, including questions regarding the diagnosis and treatment of CP and several controversial clinical case vignettes, was send by e-mail to members of various international pancreatic associations: IHPBA, APA, EPC, ESGE and DPSG.

Results: A total of 288 pancreatologists, 56% surgeons and 44% gastroenterologists, from at least 47 countries, participated in the survey. About half (48%) of the specialists used a classification tool for the diagnosis of CP, including the Mayo Clinic (28%), Mannheim (25%), or Büchler (25%) tools. Overall, CT was the preferred imaging modality for evaluation of an enlarged pancreatic head (59%), pseudocyst (55%), calcifications (75%), and peripancreatic fat infiltration (68%). MRI was preferred for assessment of main pancreatic duct (MPD) abnormalities (60%). Total pancreatectomy with auto-islet transplantation was the preferred treatment in patients with parenchymal calcifications without MPD abnormalities and in patients with refractory pain despite maximal medical, endoscopic, and surgical treatment. In patients with an enlarged pancreatic head, 58% preferred initial surgery (PPPD) versus 42% initial endoscopy. In patients with a dilated MPD and intraductal stones 56% preferred initial endoscopic ± ESWL treatment and 29% preferred initial surgical treatment.

Conclusion: Worldwide, clinical decision-making in CP is largely based on local expertise, beliefs and disbeliefs. Further development of evidence-based guidelines based on well designed (randomized) studies is strongly encouraged.
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http://dx.doi.org/10.1016/j.hpb.2017.07.006DOI Listing
November 2017

Risk of Pancreatic Cancer After a Primary Episode of Acute Pancreatitis.

Pancreas 2017 09;46(8):1018-1022

From the *Department of Surgery, Erasmus MC, University Medical Center, Rotterdam; †Department of Surgery, University Medical Center, Utrecht; ‡Department of Surgery, Maasstad Hospital, Rotterdam; §Department of Surgery, Academic Medical Center, Amsterdam; and ∥Department of Radiology, St Antonius Hospital, Nieuwegein, The Netherlands.

Objective: Acute pancreatitis may be the first manifestation of pancreatic cancer. The aim of this study was to assess the risk of pancreatic cancer after a first episode of acute pancreatitis.

Methods: Between March 2004 and March 2007, all consecutive patients with a first episode of acute pancreatitis were prospectively registered. Follow-up was based on hospital records audit, radiological imaging, and patient questionnaires. Outcome was stratified based on the development of chronic pancreatitis.

Results: We included 731 patients. The median follow-up time was 55 months. Progression to chronic pancreatitis was diagnosed in 51 patients (7.0%). In this group, the incidence rate per 1000 person-years for developing pancreatic cancer was 9.0 (95% confidence interval, 2.3-35.7). In the group of 680 patients who did not develop chronic pancreatitis, the incidence rate per 1000 person-years for developing pancreatic cancer in this group was 1.1 (95% confidence interval, 0.3-3.3). Hence, the rate ratio of pancreatic cancer was almost 9 times higher in patients who developed chronic pancreatitis compared with those who did not (P = 0.049).

Conclusions: Although a first episode of acute pancreatitis may be related to pancreatic cancer, this risk is mainly present in patients who progress to chronic pancreatitis.
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http://dx.doi.org/10.1097/MPA.0000000000000879DOI Listing
September 2017

Minimally invasive and endoscopic versus open necrosectomy for necrotising pancreatitis: a pooled analysis of individual data for 1980 patients.

Gut 2018 04 3;67(4):697-706. Epub 2017 Aug 3.

Department of Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.

Objective: Minimally invasive surgical necrosectomy and endoscopic necrosectomy, compared with open necrosectomy, might improve outcomes in necrotising pancreatitis, especially in critically ill patients. Evidence from large comparative studies is lacking.

Design: We combined original and newly collected data from 15 published and unpublished patient cohorts (51 hospitals; 8 countries) on pancreatic necrosectomy for necrotising pancreatitis. Death rates were compared in patients undergoing open necrosectomy versus minimally invasive surgical or endoscopic necrosectomy. To adjust for confounding and to study effect modification by clinical severity, we performed two types of analyses: logistic multivariable regression and propensity score matching with stratification according to predicted risk of death at baseline (low: <5%; intermediate: ≥5% to <15%; high: ≥15% to <35%; and very high: ≥35%).

Results: Among 1980 patients with necrotising pancreatitis, 1167 underwent open necrosectomy and 813 underwent minimally invasive surgical (n=467) or endoscopic (n=346) necrosectomy. There was a lower risk of death for minimally invasive surgical necrosectomy (OR, 0.53; 95% CI 0.34 to 0.84; p=0.006) and endoscopic necrosectomy (OR, 0.20; 95% CI 0.06 to 0.63; p=0.006). After propensity score matching with risk stratification, minimally invasive surgical necrosectomy remained associated with a lower risk of death than open necrosectomy in the very high-risk group (42/111 vs 59/111; risk ratio, 0.70; 95% CI 0.52 to 0.95; p=0.02). Endoscopic necrosectomy was associated with a lower risk of death than open necrosectomy in the high-risk group (3/40 vs 12/40; risk ratio, 0.27; 95% CI 0.08 to 0.88; p=0.03) and in the very high-risk group (12/57 vs 28/57; risk ratio, 0.43; 95% CI 0.24 to 0.77; p=0.005).

Conclusion: In high-risk patients with necrotising pancreatitis, minimally invasive surgical and endoscopic necrosectomy are associated with reduced death rates compared with open necrosectomy.
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http://dx.doi.org/10.1136/gutjnl-2016-313341DOI Listing
April 2018

Describing Peripancreatic Collections According to the Revised Atlanta Classification of Acute Pancreatitis: An International Interobserver Agreement Study.

Pancreas 2017 08;46(7):850-857

From the *Department of OR/Clinical Surgical Research, Radboud university medical center, Nijmegen; Departments of †Gastroenterology and Hepatology, and ‡Surgery, Academic Medical Center, Amsterdam; §Department of Radiology, St. Antonius Hospital, Nieuwegein; ∥Department of Surgery, University Medical Center Utrecht, Utrecht, The Netherlands; ¶Department of Gastroenterology, Center for Pancreatic Disease, Brigham and Women's Health Hospital, Harvard Medical School, Boston, MA; #Department of Radiology, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands; **Department of Surgery, Glasgow Royal Infirmary, Glasgow; ††Department of Surgery, Freeman Hospital, Newcastle Upon Tyne, United Kingdom; ‡‡Department of Surgery, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands; §§Department of Radiology, University of Washington Medical Center, Seattle, WA; ∥∥Department of Radiology, Radboud university medical center, Nijmegen, The Netherlands; ¶¶Department of Radiology, Mayo Clinic, Rochester, MN; ##Department of Surgery, University Hospital Southampton, Hampshire, United Kingdom; ***Department of Radiology, Academic Medical Center, Amsterdam, The Netherlands; †††Department of Medicine A, University Medicine Greifswald, Germany; ‡‡‡Department of Radiology, Beth Israel Deaconess Medical Center, Boston, MA; §§§Department of Surgery, Mayo Clinic, Rochester, MN; ∥∥∥Department of Radiology, University Hospital Southampton, Hampshire, United Kingdom; ¶¶¶Department of Gastroenterology, Mayo Clinic, Rochester, MN; ###Department of Surgery, Ludwig Maximilian University of Munich, Munich, Germany; ****Department of Clinical Research Unit, Academic Medical Center, Amsterdam, The Netherlands; and ††††Department of Surgery, University of Washington Medical Center, Seattle, WA.

Objectives: Severe acute pancreatitis is associated with peripancreatic morphologic changes as seen on imaging. Uniform communication regarding these morphologic findings is crucial for accurate diagnosis and treatment. For the original 1992 Atlanta classification, interobserver agreement is poor. We hypothesized that for the revised Atlanta classification, interobserver agreement will be better.

Methods: An international, interobserver agreement study was performed among expert and nonexpert radiologists (n = 14), surgeons (n = 15), and gastroenterologists (n = 8). Representative computed tomographies of all stages of acute pancreatitis were selected from 55 patients and were assessed according to the revised Atlanta classification. The interobserver agreement was calculated among all reviewers and subgroups, that is, expert and nonexpert reviewers; interobserver agreement was defined as poor (≤0.20), fair (0.21-0.40), moderate (0.41-0.60), good (0.61-0.80), or very good (0.81-1.00).

Results: Interobserver agreement among all reviewers was good (0.75 [standard deviation, 0.21]) for describing the type of acute pancreatitis and good (0.62 [standard deviation, 0.19]) for the type of peripancreatic collection. Expert radiologists showed the best and nonexpert clinicians the lowest interobserver agreement.

Conclusions: Interobserver agreement was good for the revised Atlanta classification, supporting the importance for widespread adaption of this revised classification for clinical and research communications.
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http://dx.doi.org/10.1097/MPA.0000000000000863DOI Listing
August 2017

The Association of Computed Tomography-Assessed Body Composition with Mortality in Patients with Necrotizing Pancreatitis.

J Gastrointest Surg 2017 06 15;21(6):1000-1008. Epub 2017 Mar 15.

Department of Surgery, St Antonius Hospital, Nieuwegein, The Netherlands.

Background: Identification of patients with necrotizing pancreatitis at high risk for a complicated course could facilitate clinical decision-making. In multiple diseases, several parameters of body composition are associated with impaired outcome, but studies in necrotizing pancreatitis are lacking.

Methods: A post hoc analysis was performed in a national prospective cohort of 639 patients with necrotizing pancreatitis. Skeletal muscle mass, skeletal muscle density, and visceral adipose tissue were measured at the third lumbar vertebra level (L3) on contrast-enhanced computed tomography (CT) within 10 days after initial admission and 1 month thereafter.

Results: In total, 496 of 639 patients (78%) were included. Overall mortality rate was 14.5%. Skeletal muscle mass and density and visceral adipose tissue on first CT were not independently associated with in-hospital mortality. However, low skeletal muscle density was independently associated with increased mortality in patients ≥65 years (OR 2.54 (95%CI 1.12-5.84, P = 0.028). Skeletal muscle mass and density significantly decreased within 1 month, for both males and females, with a median relative loss of muscle mass of 12.9 and 10.2% (both P < 0.001), respectively. Skeletal muscle density decreased with 7.2 and 7.5% (both P < 0.001) for males and females, respectively. A skeletal muscle density decrease of ≥10% in 1 month was independently associated with in-hospital mortality: OR 5.87 (95%CI 2.09-16.50, P = 0.001).

Conclusion: First CT-assessed body composition parameters do not correlate with in-hospital mortality in patients with necrotizing pancreatitis. Loss of skeletal muscle density ≥10% within the first month after initial admission, however, is significantly associated with increased mortality in these patients.
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http://dx.doi.org/10.1007/s11605-016-3352-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5443861PMC
June 2017

Magnetic resonance enterography findings of a gastrocolic fistula in Crohn's disease.

Quant Imaging Med Surg 2016 Aug;6(4):482-485

Department of Radiology, Sint Antonius Ziekenhuis, Nieuwegein, The Netherlands.

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http://dx.doi.org/10.21037/qims.2016.08.06DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5009107PMC
August 2016

Significant inter-observer variation in the diagnosis of extrapancreatic necrosis and type of pancreatic collections in acute pancreatitis - An international multicenter evaluation of the revised Atlanta classification.

Pancreatology 2016 Sep-Oct;16(5):791-7. Epub 2016 Aug 13.

Department of Radiology, St. Antonius Hospital, Nieuwegein, The Netherlands.

Background: For consistent reporting and better comparison of data in research the revised Atlanta classification (RAC) proposes new computed tomography (CT) criteria to describe the morphology of acute pancreatitis (AP). The aim of this study was to analyse the interobserver agreement among radiologists in evaluating CT morphology by using the new RAC criteria in patients with AP.

Methods: Patients with a first episode of AP who obtained a CT were identified and consecutively enrolled at six European centres backwards from January 2013 to January 2012. A local radiologist at each center and a central expert radiologist scored the CTs separately using the RAC criteria. Center dependent and independent interobserver agreement was determined using Kappa statistics.

Results: In total, 285 patients with 388 CTs were included. For most CT criteria, interobserver agreement was moderate to substantial. In four categories, the center independent kappa values were fair: extrapancreatic necrosis (EXPN) (0.326), type of pancreatitis (0.370), characteristics of collections (0.408), and appropriate term of collections (0.356). The fair kappa values relate to discrepancies in the identification of extrapancreatic necrotic material. The local radiologists diagnosed EXPN (33% versus 59%, P < 0.0001) and non-homogeneous collections (35% versus 66%, P < 0.0001) significantly less frequent than the central expert. Cases read by the central expert showed superior correlation with clinical outcome.

Conclusion: Diagnosis of EXPN and recognition of non-homogeneous collections show only fair agreement potentially resulting in inconsistent reporting of morphologic findings.
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http://dx.doi.org/10.1016/j.pan.2016.08.007DOI Listing
March 2017