Publications by authors named "James L Watkins"

49 Publications

A rare complication of ERCP: duodenal perforation due to biliary stent migration.

Endosc Int Open 2020 Nov 21;8(11):E1530-E1536. Epub 2020 Oct 21.

Division of Gastroenterology and Hepatology, Indiana University School of Medicine, Indianapolis, IN, USA.

Perforation of the duodenal wall opposing the major papilla due to a migrated pancreatobiliary stent rarely has been described in the literature as a complication of endoscopic retrograde cholangiopancreatography (ERCP). Factors associated with perforation from migrated stents from ERCP are unknown. This was a retrospective, observational study. Patients were identified from January 1, 1994 to May 31, 2019 in a prospectively maintained ERCP database. Eleven cases of duodenal perforation from migrated pancreatobiliary stents placed at ERCP were identified during the study period. All cases involved biliary stents, placed for biliary stricture management. The perforating stent was plastic in 10 cases (91 %). This complication occurred in one in 2,293 ERCP procedures in which a pancreatobiliary stent was placed. This complication is more common with biliary stents compared to pancreatic stents. This may be related to the angle of exit of biliary stents being more perpendicular to the opposing duodenal wall and the near exclusive use of external pigtail plastic stents in the pancreatic duct. All perforating plastic stents were ≥ 9 cm in length. Longer stents may provide leverage for perforation with a migration event.
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http://dx.doi.org/10.1055/a-1231-4758DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7577786PMC
November 2020

Combined Versus Separate Sessions of Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography for the Diagnosis and Management of Pancreatic Ductal Adenocarcinoma with Biliary Obstruction.

Dig Dis Sci 2020 Aug 27. Epub 2020 Aug 27.

Division of Gastroenterology and Hepatology, Indiana University School of Medicine, 550 N. University Blvd., Ste 1634, Indianapolis, IN, 46202, USA.

Background: A single-procedure session combining EUS and ERCP (EUS/ERCP) for tissue diagnosis and biliary decompression for pancreatic duct adenocarcinoma (PDAC) is technically feasible. While EUS/ERCP may offer expedience and convenience over an approach of separate procedures sessions, the technical success and risk for complications of a combined approach is unclear.

Aims: Compare the effectiveness and safety of EUS/ERCP versus separate session approaches for PDAC.

Methods: Study patients (2010-2015) were identified within our ERCP database. Patients were analyzed in three groups based on approach: Group A: Single-session EUS-FNA and ERCP (EUS/ERCP), Group B: EUS-FNA followed by separate, subsequent ERCP (EUS then ERCP), and Group C: ERCP with/without separate EUS (ERCP ± EUS). Rates of technical success, number of procedures, complications, and time to initiation of PDAC therapies were compared between groups.

Results: Two hundred patients met study criteria. EUS/ERCP approach (Group A) had a longer index procedure duration (median 66 min, p = 0.023). No differences were observed between Group A versus sequential procedure approaches (Groups B and C) for complications (p = 0.109) and success of EUS-FNA (p = 0.711) and ERCP (p = 0.109). Subgroup analysis (> 2 months of follow-up, not referred to hospice, n = 126) was performed. No differences were observed for stent failure (p = 0.307) or need for subsequent procedures (p = 0.220). EUS/ERCP (Group A) was associated with a shorter time to initiation of PDAC therapies (mean, 25.2 vs 42.7 days, p = 0.046).

Conclusions: EUS/ERCP approach has comparable rates of success and complications compared to separate, sequential approaches. An EUS/ERCP approach equates to shorter time interval to initiation of PDAC therapies.
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http://dx.doi.org/10.1007/s10620-020-06564-0DOI Listing
August 2020

Percutaneous Gastrostomy in Necrotizing Pancreatitis: Friend or Foe?

J Gastrointest Surg 2020 Dec 2;24(12):2800-2806. Epub 2019 Dec 2.

Department of Surgery, Indiana University School of Medicine, Indianapolis, IN, USA.

Background: Enteral nutrition plays a central role in managing necrotizing pancreatitis (NP). Although the nasojejunal (NJ) route is widely used, percutaneous gastrostomy (PEG-J) is an alternative technique that is also applied commonly. We hypothesized that NJ and PEG-J had similar morbidity in the setting of NP.

Methods: All patients receiving preoperative enteral nutrition before surgical debridement for NP (2005-2015) were segregated into NJ or PEG-J.

Results: A total of 242 patients had complete data for analysis (155 men/87 women; median age 54 years; 47% biliary and 16% alcohol-related pancreatitis). NJ was used exclusively in 187 patients (77%); 25 patients (10%) were fed exclusively by PEG-J; the remaining 30 patients (13%) had NJ first, followed by PEG-J. Equal proportions of NJ and PEG-J patients reached enteral feeding goal (67% vs. 68%, p ≈ 1) and increased serum albumin (39% vs. 36%, p = 0.87). No difference was seen in rate of pancreatic necrosis infection (NJ 53% vs. PEG-J 49%, p = 0.64). NJ patients had significantly more complications compared to PEG-J (51%vs.27%,p = 0.0015). However, NJ patients had more grade I/II complication, compared to PEG-J patients, who had more grade III/IV complication (Grade I/II: NJ 51%vs. PEG-J 16%; Grade III/IV NJ 0%vs. PEG-J 11%, p < 0.0001).

Conclusion: In necrotizing pancreatitis, NJ and PEG-J both delivered enteral nutrition effectively. Patients with NJ feeding had significantly more complications than those with PEG-J; however, NJ complications were less severe.
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http://dx.doi.org/10.1007/s11605-019-04469-6DOI Listing
December 2020

Rectal indometacin dose escalation for prevention of pancreatitis after endoscopic retrograde cholangiopancreatography in high-risk patients: a double-blind, randomised controlled trial.

Lancet Gastroenterol Hepatol 2020 02 25;5(2):132-141. Epub 2019 Nov 25.

Division of Gastroenterology, Medical University of South Carolina, Charleston, SC, USA.

Background: Although rectal indometacin 100 mg is effective in reducing the frequency and severity of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in high-risk patients, the optimal dose is unknown, and pancreatitis incidence remains high. The aim of this study was to compare the efficacy of two dose regimens of rectal indometacin on the frequency and severity of pancreatitis after ERCP in high-risk patients.

Methods: In this randomised, double-blind, comparative effectiveness trial, we enrolled patients from six tertiary medical centres in the USA. Eligible patients were those at high risk for the development of pancreatitis after ERCP. We randomly assigned eligible patients (1:1) immediately after ERCP to receive either two 50 mg indometacin suppositories and a placebo suppository (standard-dose group) or three 50 mg indometacin suppositories (high-dose group). 4 h after the procedure, patients assigned to the high-dose group received an additional 50 mg indometacin suppository, whereas patients in the standard-dose group received an additional placebo suppository. The randomisation schedule, stratified according to study centre and with no other restrictions, was computer generated by an investigator who was uninvolved in the clinical care of any participants, distributed to the sites, and kept by personnel not directly involved with the study. These same personnel were responsible for packaging the drug and placebo in opaque envelopes. Patients, study personnel, and treating physicians were masked to study group assignment. The primary outcome of the study was the development of pancreatitis after ERCP. Analyses were done on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov, number NCT01912716, and enrolment is complete.

Findings: Between July 9, 2013, and March 22, 2018, 1037 eligible patients were enrolled and randomly assigned to receive either standard-dose (n=515) or high-dose indometacin (n=522). Pancreatitis after ERCP occurred in 141 (14%) of 1037 patients-76 (15%) of 515 patients in the standard-dose indometacin group and 65 (12%) of 522 patients in the high-dose indometacin group (risk ratio [RR] 1·19, 95% CI 0·87-1·61; p=0·32). We observed 19 adverse events that were potentially attributable to study drug. Clinically significant bleeding occurred in 14 (1%) of 1037 patients-six (1%) of 515 patients in the standard-dose indometacin group and eight (2%) of 522 patients in the high-dose indometacin group (p=0·79). Three (1%) of 522 patients in the high-dose indometacin group developed acute kidney injury versus none in the standard-dose group (p=0·25). A non-ST elevation myocardial infarction occurred in the standard-dose indometacin group 2 days after ERCP. A transient ischaemic attack occurred in the high-dose indometacin group 5 days after ERCP. All 19 adverse events, in addition to the 141 patients who developed pancreatitis after ERCP, were considered serious as all required admission to hospital. We observed no allergic reactions or deaths at 30 day follow-up.

Interpretation: Dose escalation to rectal indometacin 200 mg did not confer any advantage compared with the standard 100 mg regimen, with pancreatitis incidence remaining high in high-risk patients. Current practice should continue unchanged. Further research should consider the pharmacokinetics of non-steroidal anti-inflammatory drugs to determine the optimal timing of their administration to prevent pancreatitis after ERCP.

Funding: American College of Gastroenterology.
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http://dx.doi.org/10.1016/S2468-1253(19)30337-1DOI Listing
February 2020

Annular pancreas: endoscopic and pancreatographic findings from a tertiary referral ERCP center.

Gastrointest Endosc 2019 02 18;89(2):322-328. Epub 2018 Sep 18.

Division of Gastroenterology and Hepatology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.

Background And Aims: Annular pancreas is a congenital anomaly whereby pancreatic tissue encircles the duodenum. Current knowledge of endoscopic findings of annular pancreas is limited to small case series. The aim of this study was to describe the endoscopic and pancreatographic findings of patients with annular pancreas at a large tertiary care ERCP center.

Methods: This is a retrospective observational study. Our Institutional Review Board-approved, prospectively collected ERCP database was queried for cases of annular pancreas. The electronic medical records were searched for patient and procedure-related data.

Results: From January 1, 1994, to December 31, 2016, 46 patients with annular pancreas underwent ERCP at our institution. Index ERCP was technically successful in 42 patients (91.3%), and technical success was achieved in all 46 patients (100%) after 2 attempts, when required. A duodenal narrowing or ring was found in most patients (n = 39, 84.8%), yet only 2 (4.3%) had retained gastric contents. Pancreas divisum was found in 21 patients (45.7%), 18 of which were complete divisum. Pancreatobiliary neoplasia was the indication for ERCP in 7 patients (15.2%). Pancreatographic findings consistent with chronic pancreatitis were noted in 15 patients (32.6%) at the index ERCP.

Conclusion: This is the largest series describing the endoscopic and pancreatographic findings of patients with annular pancreas. We found that 45.7% of patients had concurrent pancreas divisum. Endoscopic therapy was successful in most patients at our institution after 1 ERCP, and in all patients after a second ERCP. Nearly one-third of patients had findings consistent with chronic pancreatitis at the time of index ERCP. It is unclear whether this may be a feature of the natural history of annular pancreas.
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http://dx.doi.org/10.1016/j.gie.2018.09.008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6679934PMC
February 2019

Endoscopic retrieval of a proximally migrated biliary stent: digital cholangioscope to the rescue.

VideoGIE 2017 Dec 28;2(12):328-329. Epub 2017 Sep 28.

Department of Internal Medicine, Division of Gastroenterology and Hepatology, Section of Interventional Endoscopy, Indiana University School of Medicine, Indianapolis, Indiana, USA.

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http://dx.doi.org/10.1016/j.vgie.2017.07.017DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6003250PMC
December 2017

Short- and long-term outcomes from percutaneous endoscopic gastrostomy with jejunal extension.

Surg Endosc 2017 07 28;31(7):2901-2909. Epub 2016 Oct 28.

Indiana University School of Medicine, Indianapolis, IN, USA.

Background: There is a paucity of data regarding the safety and efficacy of percutaneous endoscopic gastrostomy with jejunal extension (PEG-J). We evaluated adverse events related to PEG-J and determined the clinical impact of PEG-J in those with chronic pancreatitis (CP).

Methods: This cohort study included all patients who underwent PEG-J placement in a tertiary-care academic medical center between 2010 and 2012. Main outcome measurements were (1) short- and long-term complications related to PEG-J and (2) changes in weight and hospitalizations during the 12-month period before and after PEG-J in the CP subgroup.

Results: Of 102 patients undergoing PEG-J placement, the overall technical success rate was 97 %. During a median follow-up period of 22 months (1-46 months, n = 90), at least one tube malfunction occurred in 52/90 (58 %; 177 episodes) after a median of 53 days (3-350 days), requiring a median of two tube replacements. Short-term (<30 days) tube malfunction occurred in 28/90 (31 %) and delayed in 24/90 (27 %); these included dislodgement (29 %), clogging (26 %) and kinking (14 %). In the CP subgroup (n = 58), mean body weight (kg) (70 vs. 71, p = 0.06) and body mass index (kg/m, 26 vs. 27, p = 0.05) increased post-PEG-J. Mean number of hospitalizations (5 vs. 2, p < 0.0001) and inpatient days per 12 months (22 vs. 12, p = 0.005) decreased.

Conclusions: While we observed no major complications related to PEG-J, half of patients had at least one episode of tube malfunction. In the CP subgroup, jejunal feeding via PEG-J significantly reduced the number of hospitalizations and inpatients days, while improving nutritional parameters.
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http://dx.doi.org/10.1007/s00464-016-5301-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5409872PMC
July 2017

Total pancreatectomy with islet cell transplantation vs intrathecal narcotic pump infusion for pain control in chronic pancreatitis.

World J Gastroenterol 2016 Apr;22(16):4160-7

Mohamad Mokadem, Division of Gastroenterology and Hepatology, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, Iowa, IA 52242, United States.

Aim: To evaluate pain control in chronic pancreatitis patients who underwent total pancreatectomy with islet cell transplantation or intrathecal narcotic pump infusion.

Methods: We recognized 13 patients who underwent intrathecal narcotic pump (ITNP) infusion and 57 patients who underwent total pancreatectomy with autologous islet cell transplantation (TP + ICT) for chronic pancreatitis (CP) pain control between 1998 and 2008 at Indiana University Hospital. All patients had already failed multiple other modalities for pain control and the decision to proceed with either intervention was made at the discretion of the patients and their treating physicians. All patients were evaluated retrospectively using a questionnaire inquiring about their pain control (using a 0-10 pain scale), daily narcotic dose usage, and hospital admission days for pain control before each intervention and during their last follow-up.

Results: All 13 ITNP patients and 30 available TP + ICT patients were evaluated. The mean age was approximately 40 years in both groups. The median duration of pain before intervention was 6 years and 7 years in the ITNP and TP + ICT groups, respectively. The median pain score dropped from 8 to 2.5 (on a scale of 0-10) in both groups on their last follow up. The median daily dose of narcotics also decreased from 393 mg equivalent of morphine sulfate to 8 mg in the ITNP group and from 300 mg to 40 mg in the TP + ICT group. No patient had diabetes mellitus (DM) before either procedure whereas 85% of those who underwent pancreatectomy were insulin dependent on their last evaluation despite ICT.

Conclusion: ITNP and TP + ICT are comparable for pain control in patients with CP however with high incidence of DM among those who underwent TP + ICT. Prospective comparative studies and longer follow up are needed to better define treatment outcomes.
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http://dx.doi.org/10.3748/wjg.v22.i16.4160DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4837433PMC
April 2016

Performance characteristics of EUS for locoregional evaluation of ampullary lesions.

Gastrointest Endosc 2015 Feb 5;81(2):380-8. Epub 2014 Oct 5.

Medical University of South Carolina, Charleston, South Carolina, USA.

Background: The accuracy of EUS in the locoregional assessment of ampullary lesions is unclear.

Objectives: To compare EUS with ERCP and surgical pathology for the evaluation of intraductal extension and local staging of ampullary lesions.

Design: Retrospective cohort study.

Setting: Tertiary-care referral center.

Patients: All patients who underwent EUS primarily for the evaluation of an ampullary lesion between 1998 and 2012.

Intervention: EUS.

Main Outcome Measurements: Comparison of EUS sensitivity/specificity for intraductal and local extension with ERCP and surgical pathology by using the area under the receiver-operating characteristic (AUROC) curves and outcomes of the subgroup referred for endoscopic papillectomy.

Results: We identified 119 patients who underwent EUS for an ampullary lesion, of whom 99 (83%) had an adenoma or adenocarcinoma. Compared with ERCP (n = 90), the sensitivity/specificity of EUS for any intraductal extension was 56%/97% (AUROC = 0.77; 95% confidence interval [CI], 0.64-0.89). However, when using surgical pathology as the reference (n = 102), the sensitivity/specificity of EUS (80%/93%; AUROC = 0.87; 95% CI, 0.76-0.97) and ERCP (83%/93%; AUROC = 0.88; 95% CI, 0.77-0.99) were comparable. The overall accuracy of EUS for local staging was 90%. Of 58 patients referred for endoscopic papillectomy, complete resection was achieved in 53 (91%); in those having intraductal extension by EUS or ERCP, complete resection was achieved in 4 of 5 (80%) and 4 of 7 (57%), respectively.

Limitation: Retrospective design.

Conclusions: EUS and ERCP perform similarly in evaluating intraductal extension of ampullary adenomas. Additionally, EUS is accurate in T-staging ampullary adenocarcinomas. Future prospective studies should evaluate whether EUS can identify characteristics of ampullary lesions that appropriately direct patients to endoscopic or surgical resection.
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http://dx.doi.org/10.1016/j.gie.2014.08.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4322681PMC
February 2015

Evaluating Adults With Idiopathic Pancreatitis for Genetic Predisposition: Higher Prevalence of Abnormal Results With Use of Complete Gene Sequencing.

Pancreas 2015 Jan;44(1):116-21

From the Division of Gastroenterology and Hepatology, Department of Internal Medicine, Indiana University School of Medicine, Indianapolis, IN.

Objectives: In adults with unexplained pancreatitis, the yield of complete gene versus select exosome sequencing on mutation detection and distinguishing clinical characteristics associated with mutations requires clarification. We sought to (1) compare frequency of mutations identified using different techniques and (2) compare clinical characteristics between adults with and without mutations.

Methods: This is a cohort study of adults with unexplained pancreatitis who underwent genetic testing between January 2008 and December 2012. We compare probabilities of having a positive mutation with complete gene sequencing versus alternatives and describe differences in characteristics among patients with and without mutations.

Results: Of the 370 patients, 67 (18%) had a genetic mutation; 24 (6%) were of high risk. Mutations were significantly more prevalent with use of complete sequencing (42%) versus other approaches (8%, P < 0.0001). Most (44/67, 66%) with a mutation had no family history. Those with high-risk mutations were more likely to have a family history of chronic pancreatitis (21% vs 4%, P = 0.002). Patients with pancreas divisum were more likely to have mutations (27% vs 14%, P = 0.0007).

Conclusion: Among individuals with adult-onset pancreatic disease, the probability of finding any mutation, including high risk, is significantly higher using complete gene sequencing. The impact on patients and providers requires further investigation.
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http://dx.doi.org/10.1097/MPA.0000000000000225DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4262640PMC
January 2015

Prevalence and risk factors for musculoskeletal injuries related to endoscopy.

Gastrointest Endosc 2015 Feb 10;81(2):294-302.e4. Epub 2014 Aug 10.

Indiana University School of Medicine, Indianapolis, Indiana, USA.

Background: There are limited data regarding work-related injury among endoscopists.

Objective: To define the prevalence of endoscopy-related musculoskeletal injuries and their impact on clinical practice and to identify physician and practice characteristics associated with their development.

Design: Survey.

Setting: Electronic survey of active members of the American Society for Gastrointestinal Endoscopy with registered e-mail addresses.

Participants: Physicians who currently or ever performed endoscopy and responded to the survey between February 2013 and November 2013.

Intervention: A 25-question, self-administered, electronic survey.

Main Outcome Measurements: Prevalence, location, and ramifications of work-related injuries and endoscopist characteristics and workload parameters associated with endoscopy-related injury.

Results: The survey was completed by 684 endoscopists. Of those, 362 (53%) experienced a musculoskeletal injury perceived definitely (n = 204) or possibly (n = 158) related to endoscopy. Factors associated with a higher rate of endoscopy-related injury included higher procedure volume (>20 cases/week; P < .001), greater number of hours per week spent performing endoscopy (>16 hours/week; P < .001), and total number of years performing endoscopy (P = .004). The most common sites of injury were neck and/or upper back (29%) and thumb (28%). Only 55% of injured endoscopists used practice modifications in response to injuries. Specific treatments included medications (57%), steroid injection (27%), physiotherapy (45%), rest (34%), splinting (23%), and surgery (13%).

Limitations: Self-reported data of endoscopy-related injury.

Conclusion: Among endoscopists there is a high prevalence of injuries definitely or potentially related to endoscopy. Higher procedure volume, more time doing endoscopy per week, and cumulative years performing endoscopy are associated with more work-related injuries.
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http://dx.doi.org/10.1016/j.gie.2014.06.036DOI Listing
February 2015

Endoscopic papillectomy: risk factors for incomplete resection and recurrence during long-term follow-up.

Gastrointest Endosc 2014 Feb 1;79(2):289-96. Epub 2013 Oct 1.

Indiana University School of Medicine, Indianapolis, Indiana, USA.

Background: Endoscopic papillectomy is increasingly used as an alternative to surgery for ampullary adenomas and other noninvasive ampullary lesions.

Objective: To measure short-term safety and efficacy of endoscopic papillectomy, define patient and lesion characteristics associated with incomplete endoscopic resection, and measure adenoma recurrence rates during long-term follow-up.

Design: Retrospective cohort study.

Setting: Tertiary-care academic medical center.

Patients: All patients who underwent endoscopic papillectomy for ampullary lesions between July 1995 and June 2012.

Intervention: Endoscopic papillectomy.

Main Outcome Measurements: Patient and lesion characteristics associated with incomplete endoscopic resection and ampullary adenoma-free survival analysis.

Results: We identified 182 patients who underwent endoscopic papillectomy, 134 (73.6%) having complete resection. Short-term adverse events occurred in 34 (18.7%). Risk factors for incomplete resection were jaundice at presentation (odds ratio [OR] 0.21; 95% confidence interval [CI] 0.07-0.69; P = .009), occult adenocarcinoma (OR 0.06; 95% CI, 0.01-0.36; P = .002), and intraductal involvement (OR 0.29; 95% CI, 0.11-0.75; P = .011). The en bloc resection technique was strongly associated with a higher rate of complete resection (OR 4.05; 95% CI, 1.71-9.59; P = .001). Among patients with ampullary adenoma who had complete resection (n = 107), 16 patients (15%) developed recurrence up to 65 months after resection.

Limitations: Retrospective analysis.

Conclusion: Jaundice at presentation, occult adenocarcinoma in the resected specimen, and intraductal involvement are associated with a lower rate of complete resection, whereas en bloc papillectomy increases the odds of complete endoscopic resection. Despite complete resection, recurrence was observed up to 5 years after papillectomy, confirming the need for long-term surveillance.
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http://dx.doi.org/10.1016/j.gie.2013.08.006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4413454PMC
February 2014

ERCP via gastrostomy vs. double balloon enteroscopy in patients with prior bariatric Roux-en-Y gastric bypass surgery.

Surg Endosc 2013 Aug 21;27(8):2894-9. Epub 2013 Jun 21.

Division of Gastroenterology/Hepatology, Department of Medicine, Indiana University Medical Center, 550 N. University Boulevard, UH 4100, Indianapolis, IN 46202, USA.

Background: Roux-en-Y gastric bypass (RYGB) is the most common bariatric surgery. The performance of ERCP in bariatric RYGB is challenging due to the long Roux limb. We herein compared the indications and technical outcomes of ERCP via percutaneous gastrostomy (GERCP) and double balloon enteroscopy (DBERCP) for patients with prior bariatric RYGB anatomy.

Methods: Between December 2005 and November 2011, consecutive ERCP patients who had undergone RYGB were identified using a prospectively maintained electronic ERCP database. Medical records were abstracted for ERCP indications and outcomes. In most cases, the gastrostomy was done by either laparoscopic or open surgery and allowed to mature at least 1 month before performing ERCP. The choice of route for ERCP was at discretion of managing physician.

Results: Forty-four patients (F = 42) with GERCP and 28 patients (F = 26) with DBERCP were identified. The mean age was younger in GERCP than DBERCP (44.8 vs. 56.1, p < 0.001). GERCP patients were more likely to have suspected sphincter of Oddi dysfunction (77 %) as the primary indication whereas DBERCP was suspected CBD stone (57 %). The mean total number of sessions/patient in GERCP and DBERCP was 1.7 ± 1.0 and 1.1 ± 0.4, respectively (p = 0.004). GERCP access to the major papilla was successful in all but two (97 %), whereas duct cannulation and interventions were successful in all. In DBERCP, the success rate of accessing major papilla, cannulation and therapeutic intervention was 78, 63, 56 %, respectively. There was one (3.1 %) post-ERCP pancreatitis in DBERCP. Complications occurred in 11 GERCP procedures (14.5 %) and 10 were related to the gastrostomy. This was significantly higher than that of DBERCP (p = 0.022).

Conclusions: GERCP is more effective than DBERCP in gaining access to the pancreatobiliary tree in patients with RYGB, but it is hindered by the gastrostomy maturation delay and a higher morbidity. Technical improvements in each method are needed.
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http://dx.doi.org/10.1007/s00464-013-2850-6DOI Listing
August 2013

Hereditary pancreatitis: endoscopic and surgical management.

J Gastrointest Surg 2013 May 23;17(5):847-56; discussion 856-7. Epub 2013 Feb 23.

Department of Surgery, Indiana University Medical Center, Indianapolis, IN 46202, USA.

Introduction: Hereditary pancreatitis is a rare cause of chronic pancreatitis. In recent years, genetic mutations have been characterized. The rarity of this disorder has resulted in a gap in clinical knowledge. The aims were to characterize patients with hereditary pancreatitis and establish clinical guidelines.

Methods: Pediatric and adult endoscopic, surgical, radiologic, and genetic databases from 1998 to 2012 were searched. Patients with recurrent acute or chronic pancreatitis and genetic mutation for either PRSS-1, SPINK-1, or CFTR or those who met the family history criteria were included. Patients with pancreatitis due to other causes, without a positive family history, familial pancreatic cancer, or cystic fibrosis, were excluded.

Results: Eighty-seven patients were identified. Genetic testing confirmed the diagnosis in 54 patients (62 %). Eighty-five patients (98 %) underwent 263 endoscopic procedures including sphincterotomy (72 %), stone removal (49 %), and pancreatic duct stenting (82 %). Twenty-eight patients (32 %) have undergone 37 operations which included 19 resections and 18 drainage procedures. The interval between procedures for recurrent pain was longer for surgery than for endoscopic therapy (9.1 vs. 3.4 years, p < 0.05).

Conclusions: Most children and young adults with hereditary pancreatitis can be managed initially with endoscopic therapy. When surgery is undertaken, the procedure should be tailored to the pancreatic anatomy and cancer risk.
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http://dx.doi.org/10.1007/s11605-013-2167-8DOI Listing
May 2013

Oral administration of edible oil before ERCP: effect on selective biliary cannulation.

Gastrointest Endosc 2013 Jan;77(1):55-61

Division of Gastroenterology, University of Florida, Gainesville, FL 32610, USA.

Background: A fatty meal before ERCP relaxes the sphincter of Oddi and may facilitate biliary cannulation.

Objective: To assess the effect of an oral fatty meal before ERCP on time to and success rate of biliary cannulation.

Design: Human clinical study.

Setting: Tertiary ERCP center.

Patients: Adult patients with intact papilla undergoing ERCP for presumed biliary pathology.

Interventions: Patients arriving more than 1 hour before the procedure were given oil by mouth. Patients not receiving oil served as controls. The need for a precut sphincterotomy was considered a failure of initial cannulation.

Main Outcome Measurements: Appearance of the papillary orifice, bile flow, cannulation success rate, cannulation and fluoroscopy times.

Results: A total of 86 patients received oil (mean age 52.8 years; 40% male), and 103 patients served as controls (mean age 53.3 years; 49% male). The papillary orifice was open in 52 of 86 (61%) and 38 of 103 (37%) patients in the oil and control groups, respectively (P = .002). Bile flow was seen in 59 of 86 (68%) and 50 of 103 (49%) patients, respectively (P = .009). The overall initial biliary cannulation success rate was 80 of 86 (93%) and 97 of 103 (94%), respectively (P = .77). There was no difference in cannulation success rates, cannulation, and fluoroscopy times for fellows or faculty endoscopists in each group. No pulmonary aspiration was seen in either group.

Limitations: Unblinded study.

Conclusions: The biliary orifice appeared more open and bile flow was seen in more patients receiving oil, but there was no difference in successful biliary cannulation rates and cannulation and fluoroscopy times in the 2 groups.
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http://dx.doi.org/10.1016/j.gie.2012.08.039DOI Listing
January 2013

Does leaving a main pancreatic duct stent in place reduce the incidence of precut biliary sphincterotomy-associated pancreatitis? A randomized, prospective study.

Gastrointest Endosc 2013 Feb 22;77(2):209-16. Epub 2012 Oct 22.

Division of Gastroenterology/Hepatology, Indiana University Medical Center, Indianapolis, Indiana 46202, USA.

Background: Pancreatitis is the most common major complication of ERCP and precut endoscopic sphincterotomy (ES). Prophylactic pancreatic duct (PD) stent placement has been shown to reduce the incidence and severity of post-ERCP pancreatitis (PEP) in high-risk settings.

Objective: To determine whether leaving a main PD stent in place after precut ES would reduce the incidence and severity of PEP.

Design: Single-center, randomized, prospective study.

Setting: Tertiary care ERCP referral center.

Patients: Consecutive patients who underwent ERCP with a clear indication for biliary access and standard biliary ES whereby free cannulation of the bile duct was not possible and precut ES was undertaken.

Interventions: When free bile duct cannulation for ES was not possible and selective PD cannulation was achieved, a PD stent was placed. Using the PD stent as a guide, we used a needle-knife sphincterotome to perform precut ES. The patients were then randomized to either leaving the PD stent in place for 7 to 10 days (stent group) or immediate removal after the procedure (stent removed group). The remaining patients who did not undergo selective PD cannulation and stent placement were not randomized (no stent group) and had a free-hand needle-knife ES performed.

Main Outcome Measurements: Patients were prospectively followed for the development of complications. Standardized criteria were used to diagnose and grade the severity of PEP.

Results: A total of 151 patients were enrolled. The groups were similar with regard to patient demographics and patient and procedure risk factors for PEP. The overall incidence of PEP was 13.2% (20/151). It occurred in 4.3% (2/46), 21.3% (10/47), and 13.8% (8/58) of patients in the stent, stent removed, and no stent groups, respectively. The stent group had a significantly lower frequency and severity of PEP compared with the stent removed group (4.3% vs 21.3%; P = .027 for frequency and 0% vs 12.8%; P = .026 for moderate and severe pancreatitis).

Limitations: Single center. Randomization scheme not optimal.

Conclusions: These data suggest that placing and maintaining a PD stent for needle-knife precut ES reduces the frequency and severity of postprocedure pancreatitis.
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http://dx.doi.org/10.1016/j.gie.2012.08.022DOI Listing
February 2013

Use of intravenous secretin during extracorporeal shock wave lithotripsy to facilitate endoscopic clearance of pancreatic duct stones.

Pancreatology 2012 May-Jun;12(3):272-5. Epub 2012 Feb 24.

Indiana University School of Medicine, IN 46202-5149, Indianapolis.

Background/aims: Pancreatic duct calcifications are common in chronic pancreatitis. Secretin (SEC) stimulates pancreas duct cells to secrete bicarbonate-rich fluid. SEC may aid fragmentation and facilitate excretion of pulverized pancreatic stones during extracorporeal shock wave lithotripsy (ESWL). The aim was to evaluate the effect of SEC administered during ESWL on clearance of main pancreatic stone (MPDS) at endoscopic retrograde cholangiopancreatography (ERCP).

Methods: Between Jan. 2003 and Sept. 2010, patients with MPDS who were treated with ESWL and ERCP were identified retrospectively. The number and diameter of calcifications were assessed at pre-ESWL images. Before 2006, ESWL was performed without SEC stimulation. From 2007, 16 μg of SEC was administered IV near the beginning of ESWL at the discretion of the managing physician. Clearance of the pancreatic duct was assessed with ERCP after ESWL.

Results: A total of 233 consecutive cases (SEC group: 71, no SEC group: 162) were tallied. Overall there were 310 ESWLs and 332 ERCPs in the 233 cases. On univariate analysis, the use of SEC showed significantly higher rate of complete MPDS clearance (63% vs. 46%, p = 0.021) after first ESWL/ERCP. The number of repeat sessions of ESWL/ERCP was similar between the two groups (SEC vs. No SEC, ESWL/ERCP: 1.27 vs. 1.36/1.34 vs. 1.46). Independent predictors of complete/nearly complete stone clearance included the use of SEC (p = 0.005), pre-ESWL pancreatic stent (p = 0.001).

Conclusions: Secretin during ESWL appears to aid clearance of MPDS in chronic calcific pancreatitis. Further prospective randomized studies would be of interest.
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http://dx.doi.org/10.1016/j.pan.2012.02.012DOI Listing
November 2012

Low yield of significant findings on endoscopic retrograde cholangiopancreatography in patients with pancreatobiliary pain and no objective findings.

Dig Dis Sci 2012 Dec 2;57(12):3252-7. Epub 2012 Jun 2.

Division of Gastroenterology, Indiana University School of Medicine, 1050 Wishard Blvd, RG 4100, Indianapolis, IN 46202-2872, USA.

Background: Due to the challenging nature of the type III sphincter of the Oddi dysfunction (SOD) patient, the suspected low diagnostic yield from endoscopic retrograde cholangiopancreatography (ERCP), the high complication rate, and the potential for litigation it is surprising that diagnostic ERCP continues to be performed in this patient population.

Aims: The purpose of this study was to determine the incidence of significant findings on ERCP alone in patients with disabling abdominal pain of suspected pancreatobiliary origin and no objective findings.

Methods: Entry criteria of this study included: (1) ERCP with attempt at visualization of both the biliary tree and pancreatic duct, (2) suspected of having abdominal pain of pancreatobiliary origin, (3) biliary or pancreatic type III by the modified Geenen-Hogan classification, (4) never undergone sphincterotomy, (5) attempted manometry of both sphincters. A total of 265 patients met entry criteria.

Results: Significant findings were found in seven patients (2.6 %): choledococoele (1), anomalous pancreatobiliary ductal union (2), mild-moderate chronic pancreatitis (2), and pancreatic duct filling defect suspicious for IPMN (2). Potentially significant in 25 patients (9.4 %) were: equivocal chronic pancreatitis (1), incomplete (4) and complete pancreas divisum (20). SOD was diagnosed in 77.7 %. 11.3 % had undergone a previous diagnostic ERCP.

Conclusion: ERCP in this high-risk population requires detailed informed consent, availability of SOM to increase the diagnostic yield, and skills in placing prophylactic pancreatic stents. It is our belief that patients without objective findings of pancreatobiliary disease that would explain their subjective complaints should not undergo diagnostic ERCP.
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http://dx.doi.org/10.1007/s10620-012-2250-0DOI Listing
December 2012

A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis.

N Engl J Med 2012 Apr;366(15):1414-22

Division of Gastroenterology, University of Michigan Medical Center, Ann Arbor, MI 48109, USA.

Background: Preliminary research suggests that rectally administered nonsteroidal antiinflammatory drugs may reduce the incidence of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP).

Methods: In this multicenter, randomized, placebo-controlled, double-blind clinical trial, we assigned patients at elevated risk for post-ERCP pancreatitis to receive a single dose of rectal indomethacin or placebo immediately after ERCP. Patients were determined to be at high risk on the basis of validated patient- and procedure-related risk factors. The primary outcome was post-ERCP pancreatitis, which was defined as new upper abdominal pain, an elevation in pancreatic enzymes to at least three times the upper limit of the normal range 24 hours after the procedure, and hospitalization for at least 2 nights.

Results: A total of 602 patients were enrolled and completed follow-up. The majority of patients (82%) had a clinical suspicion of sphincter of Oddi dysfunction. Post-ERCP pancreatitis developed in 27 of 295 patients (9.2%) in the indomethacin group and in 52 of 307 patients (16.9%) in the placebo group (P=0.005). Moderate-to-severe pancreatitis developed in 13 patients (4.4%) in the indomethacin group and in 27 patients (8.8%) in the placebo group (P=0.03).

Conclusions: Among patients at high risk for post-ERCP pancreatitis, rectal indomethacin significantly reduced the incidence of the condition. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT00820612.).
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http://dx.doi.org/10.1056/NEJMoa1111103DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3339271PMC
April 2012

Acute pancreatitis after removal of retained prophylactic pancreatic stents.

Gastrointest Endosc 2011 May;73(5):980-6

Division of Gastroenterology, Indiana University, Indianapolis, Indiana, USA; Department of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.

Background: Prophylactic pancreatic stents (PPSs) are used to decrease the risk of post-ERCP pancreatitis (PEP) in high-risk patients. The risk associated with PPS removal is unknown.

Objective: To describe the rate of PEP in patients undergoing PPS removal without pancreatogram or other manipulation of the major or minor papilla.

Design: Retrospective, cohort study.

Setting: Tertiary care academic center.

Patients: This study involved 230 patients undergoing removal of PPSs from 1997 to 2010.

Intervention: PPS removal.

Main Outcome Measurements: Rate of acute pancreatitis associated with removal of PPS alone.

Results: Acute pancreatitis occurred after PPS removal in 7 of 230 (3.0%) cases. PEP was graded as mild, moderate, and severe in 2, 5, and 0 cases, respectively. Statistically significant risk factors of PEP after PPS removal include use of a 5F stent (P=.001), use of a stent with an internal flange (P<.01), and occurrence of PEP after the initial ERCP (P<.01). Longer duration of stent within the pancreatic duct before removal was of borderline significance (P=.06). Patient age; sex; indication for initial procedure; the presence of pancreas divisum, ansa loop, or chronic pancreatitis; and history of pancreatic or biliary sphincterotomy or orifice dilation were not significant risk factors for pancreatitis after PPS removal.

Limitations: Retrospective analysis of prospectively collected data. Small number of events.

Conclusion: Removal of retained PPSs may cause mild or moderate acute pancreatitis. This risk of acute pancreatitis may diminish the overall efficacy of PPS use by delaying the occurrence of PEP rather than eliminating it. This implies that PPSs should be used only in patients at high risk for PEP.
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http://dx.doi.org/10.1016/j.gie.2011.01.012DOI Listing
May 2011

Risk factors for ERCP-related complications in patients with pancreas divisum: a retrospective study.

Gastrointest Endosc 2011 May 9;73(5):963-70. Epub 2011 Mar 9.

Indiana University, Indianapolis, Indiana, USA.

Background: Limited data are available on complication rates of ERCP in patients with pancreas divisum (PD), and it is unclear whether traditional risk factors for post-ERCP pancreatitis (PEP) apply.

Objectives: To describe the rates of ERCP complications in patients with PD and assess patient and procedure-related risk factors for PEP.

Design: Retrospective cohort study.

Setting: Tertiary care referral center.

Patients: A total of 2753 ERCPs performed in 1476 patients with PD from 1997 to 2010.

Main Outcome Measurements: Rates of PEP, hemorrhage, perforation, cholecystitis, and hospitalization directly attributable to ERCP.

Results: Early complications occurred after 7.8% of procedures, with PEP, hemorrhage, perforation, cholecystitis, and cardiorespiratory complications in 6.8%, 0.7%, 0.2%, 0.1%, and 0.1% of procedures, respectively. PEP was uncommon in patients who did not undergo attempted dorsal duct cannulation, occurring in 1.2% of procedures. With dorsal duct cannulation and cannulation with minor papilla sphincterotomy (MiS), the rates of PEP increased significantly to 8.2% and 10.6%, respectively (P<.01 for each comparison). Significant predictors of PEP after multivariate logistic regression included age younger than 40 (odds ratio [OR] 1.8; 95% CI, 1.27-2.59), female sex (OR 1.94; 95% CI, 1.25-3.01), previous PEP (OR 2.02; 95% CI, 1.32-3.1), attempted dorsal duct cannulation (OR 7.45; 95% CI, 3.25-17.07), and MiS (OR 1.62; 95% CI, 1.05-2.48). Presence of severe chronic pancreatitis was a protective factor (OR 0.46; 95% CI, 0.22-0.98).

Limitations: Retrospective analysis of prospectively collected data.

Conclusions: Among patients with PD, the rate of PEP is low (1.2%) if dorsal duct cannulation is not attempted. However, patients with PD undergoing dorsal duct cannulation with or without MiS are at high risk of PEP (8.2% without and 10.6% with). Traditional PEP risk factors apply to patients with PD.
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http://dx.doi.org/10.1016/j.gie.2010.12.035DOI Listing
May 2011

Role of EUS for preoperative evaluation of cholangiocarcinoma: a large single-center experience.

Gastrointest Endosc 2011 Jan 9;73(1):71-8. Epub 2010 Nov 9.

Division of Gastroenterology and Hepatology, Indiana University School of Medicine, Indianapolis, Indiana 46202, USA.

Background: Accurate preoperative diagnosis and staging of cholangiocarcinoma (CCA) remain difficult.

Objective: To evaluate the utility of EUS in the diagnosis and preoperative evaluation of CCA.

Design: Observational study of prospectively collected data.

Setting: Single tertiary referral hospital in Indianapolis, Indiana.

Patients: Consecutive patients with CCA from January 2003 through October 2009.

Interventions: EUS and EUS-guided FNA (EUS-FNA).

Main Outcome Measurements: Sensitivity of EUS for the detection of a tumor and prediction of unresectability compared with CT and magnetic resonance imaging (MRI); sensitivity of EUS-FNA to provide tissue diagnosis, by using surgical pathology as a reference standard.

Results: A total of 228 patients with biliary strictures undergoing EUS were identified. Of these, 81 (mean age 70 years, 45 men) had CCA. Fifty-one patients (63%) had distal and 30 (37%) had proximal CCA. For those with available imaging, tumor detection was superior with EUS compared with triphasic CT (76 of 81 [94%] vs 23 of 75 [30%], respectively; P < .001). MRI identified the tumor in 11 of 26 patients (42%; P = .07 vs EUS). EUS identified CCA in all 51 (100%) distal and 25 (83%) of 30 proximal tumors (P < .01). EUS-FNA (median, 5 passes; range, 1-12 passes) was performed in 74 patients (91%). The overall sensitivity of EUS-FNA for the diagnosis of CCA was 73% (95% confidence interval, 62%-82%) and was significantly higher in distal compared with proximal CCA (81% vs 59%, respectively; P = .04). Fifteen tumors were definitely unresectable. EUS correctly identified unresectability in 8 of 15 and correctly identified the 38 of 39 patients with resectable tumors (53% sensitivity and 97% specificity for unresectability). CT and/or MRI failed to detect unresectability in 6 of these 8 patients.

Limitation: Single-center study.

Conclusion: EUS and EUS-FNA are sensitive for the diagnosis of CCA and very specific in predicting unresectability. The sensitivity of EUS-FNA is significantly higher in distal than in proximal CCA.
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http://dx.doi.org/10.1016/j.gie.2010.08.050DOI Listing
January 2011

Endoscopic retrograde cholangiopancreatography and manometry findings in 1,241 idiopathic pancreatitis patients.

Pancreatology 2010 19;10(4):444-52. Epub 2010 Aug 19.

Department of Medicine, Indiana University, Indianapolis, Ind 46202, USA.

Background: 10-30% of patients with pancreatitis are classified as idiopathic after the initial evaluation. Our aim was to assess the diagnostic yield of endoscopic retrograde cholangiopancreatography (ERCP) and sphincter of Oddi manometry in patients with idiopathic pancreatitis in a tertiary referral center.

Methods: A single-center, retrospective study analyzing the ERCP and manometry results of 1,241 patients who were classified as having idiopathic pancreatitis based upon their initial evaluation.

Results: A single episode of pancreatitis occurred in 20.4%, acute recurrent pancreatitis in 56.3% and chronic pancreatitis in 23.3% of the patients undergoing ERCP. Sphincter of Oddi dysfunction was found in 40.3% and pancreas divisum in 18.8% of the patients. Biliary stone disease was found in 3.0%. Intraductal papillary mucinous neoplasms were identified in 52 patients with increasing frequency in older age groups. The overall diagnostic yield of ERCP and sphincter of Oddi manometry to elucidate a potential cause of pancreatitis was 65.8%. Of these, 91.9% patients had findings amenable to endoscopic therapy. The complication rate was 11.5%.

Conclusions: In this large series, ERCP with manometry frequently identified conditions which probably caused or contributed to the idiopathic pancreatitis. Long-term studies are awaited to determine outcomes after correctable factors are addressed. and IAP.
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http://dx.doi.org/10.1159/000264675DOI Listing
January 2011

Therapeutic EUS-assisted endoscopic retrograde pancreatography after failed pancreatic duct cannulation at ERCP.

Gastrointest Endosc 2010 Jun 19;71(7):1166-73. Epub 2010 Mar 19.

Division of Gastroenterology and Hepatology, Indiana University Medical Center, Indianapolis, Indiana, USA.

Background: Cannulation of the pancreatic duct (PD) during endoscopic retrograde pancreatography (ERP) can fail even in experienced hands. A technique for therapeutic EUS-assisted rendezvous ERP has been described in a few case reports.

Objective: To investigate the efficacy and safety of therapeutic EUS-assisted ERP.

Design: Retrospective study.

Setting: Tertiary-care medical center.

Patients: This study involved 21 patients after failed ERP.

Intervention: EUS-guided transgastric pancreatography by using a mixture of contrast media and methylene blue was attempted. If that was successful, ERP was attempted by using methylene blue flow as an indicator of the PD orifice or by a rendezvous technique using a wire passed into the PD and the small bowel through the EUS needle.

Main Outcome Measurements: Technical success rate and complications.

Results: The PD was of a normal diameter in 7 patients and was dilated in 14 patients. EUS-guided pancreatography was successfully done in all patients with a dilated PD but only in 4 of 7 patients (57%) with normal-diameter PDs. In 6 patients, ERP was successfully performed by using methylene blue flow as an indicator of the PD orifice. The rendezvous technique was successful in 4 of 12 cases (33%), and reasons for failure were either a tight stricture (n = 5) or a suboptimal angle of EUS needle insertion (n = 3). Overall, EUS-assisted ERP was successful in 10 of 21 patients (48%). Complications included peripancreatic abscess in 1 patient and mild pancreatitis in 1 patient.

Limitations: Retrospective study, small sample size.

Conclusion: EUS-assisted ERP is a complex procedure that can provide access to the PD in selected cases after failed standard ERP.
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http://dx.doi.org/10.1016/j.gie.2009.10.048DOI Listing
June 2010

Endoscopic retrograde pancreatography.

Clin Gastroenterol Hepatol 2009 Sep 10;7(9):931-43. Epub 2009 Jun 10.

Division of Gastroenterology and Hepatology, Indiana University Hospital, Indianapolis, Indiana 46202, USA.

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http://dx.doi.org/10.1016/j.cgh.2009.06.002DOI Listing
September 2009

Intrathecal narcotic infusion pumps for intractable pain of chronic pancreatitis: a pilot series.

Am J Gastroenterol 2009 May 14;104(5):1249-55. Epub 2009 Apr 14.

Indiana University Medical Center, Indianapolis, Indiana 46202, USA.

Objectives: The aim of this study was to evaluate the efficacy of intrathecal narcotics pump (ITNP) as an alternative treatment for patients with pain from chronic pancreatitis (CP). ITNP offers the advantages of reversibility, lower total narcotic dose, and the pancreas remaining intact.

Methods: Thirteen patients (8 female, 5 male), with mean age 40.6 years (s.d. 9.6 years), who had experienced intractable upper abdominal pain from CP were reviewed. Each patient had multiple other failed treatment modalities, including partial pancreatic resection (n = 6). They were offered ITNP after a successful intraspinal opioid trial. Etiologies of CP included idiopathy (n = 3), cystic fibrosis (n = 2), alcohol (n = 2), and pancreas divisum (n = 6).

Results: The median duration of severe, intractable pain prior to ITNP was 6 years (2-22 years). The median follow-up time after ITNP was 29 months (range, 7-94 months). The ITNP was in situ for a mean duration of 29 months (range, 0.5-94 months). Seven patients had pump exchange or removal for various reasons; improvement of pain at month 53 (n = 1), meningitis (n = 1), meningitis with subsequent replacement (n = 1), pump failure at month 31, 68, 79, and 84 (n = 4). There were no deaths. The mean pain score prior to implantation (score = 8.3, s.d. = 0.9) was significantly higher than 1 year after (score = 2.7, s.d. = 1.9) (P < 0.01) and last follow-up (score = 0.75, s.d. = 2.1) (P < 0.01). The median oral narcotic dose before and 1 year after ITNP were morphine sulfate equivalents 337.5 mg per day (range, 67.5-1,320) and 40 mg per day (range, 0-1,680), respectively (P < 0.01). Two patients were considered failures, as they still require a high dosage of both oral and intrathecal medications to control their pain, despite significant pain-score improvement. One patient who was excluded due to meningitis was also considered a failure. Therefore, the overall success rate of ITNP based on an intention-to-treat analysis was 76.9% (10/13). The major complications of ITNP were central nervous system infection requiring pump removal (n = 1), cerebrospinal fluid leak requiring laminectomy (n = 1), and perispinal abscess with bacterial meningitis requiring pump removal (n = 1).

Conclusions: This study shows the many risks and benefits of ITNP. A longer follow-up is awaited; such pumps appear to be one alternative to aggressive surgical intervention. Failed ITNP trials leave other options open. Therapeutic trials directly comparing pancreatectomy, ITNP, and implanted nerve stimulators are of interest.
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http://dx.doi.org/10.1038/ajg.2009.54DOI Listing
May 2009

Does obesity confer an increased risk and/or more severe course of post-ERCP pancreatitis?: a retrospective, multicenter study.

J Clin Gastroenterol 2008 Nov-Dec;42(10):1103-9

Indiana University Medical Center, Indianapolis, IN 46202, USA.

Background: Pancreatitis is the most common major complication of endoscopic retrograde cholangiopancreatography (ERCP). Recent studies have suggested that obesity may serve as a prognostic indicator of poor outcome in non-ERCP-induced acute pancreatitis. However, to our knowledge, no one has ever investigated the potential association of obesity and ERCP-induced pancreatitis. Thus, the purpose of our study was to determine whether obesity conferred an increased risk and/or more severe course of post-ERCP pancreatitis.

Methods: A 160 variable database was prospectively collected by a defined protocol on patients undergoing diagnostic or therapeutic ERCP at 15 centers in the Midwest Pancreaticobiliary Group and participating in a randomized controlled study, evaluating whether prophylactic corticosteroids reduces the incidence of post-ERCP pancreatitis. Body mass indices (BMIs) were available on 964 of the 1115 patients from the original study. A BMI > or = 30 kg/m2 was defined as obese (World Health Organization) and used as a cutoff point in this study. BMIs were analyzed in a retrospective fashion to determine whether obesity confers an increased risk and/or more severe course of post-ERCP pancreatitis. Data were collected before the ERCP, at the time of procedure, and 24 to 72 hours after discharge. Standardized criteria were used to diagnose and grade the severity of postprocedure pancreatitis.

Results: Nine hundred sixty four patients were enrolled in the study. Pancreatitis occurred in 149 patients (15.5%) and was graded as mild in 101 (67.8%), moderate in 42 (28.2%), and severe in 6 (4.0%). The patients were categorized by BMI (kg/m2) using the following breakdowns: BMI < 20, 20 to < 25, 25 to < 30, and > or = 30, as well as BMI < 30 or > or = 30. The groups were similar with respect to the patient and procedure risk factors for post-ERCP pancreatitis except the group with BMI > or = 30 had a higher frequency of females, were younger, had less frequent chronic pancreatitis, a lower number of pancreatic duct injections, and fewer patients received more than 2 pancreatic duct injections. Of the patients with a BMI < 30, 119 (16.4%) developed post-ERCP pancreatitis compared with 30 (12.5%) of those with a BMI > or = 30 (P=0.14). There was no association between the presence of obesity and the severity of pancreatitis (P=0.74). Patients with a BMI < 20, 20 to < 25, 25 to < 30, and > or = 30 had a similar incidence of post-ERCP pancreatitis.

Conclusions: Obesity did not seem to confer an increased risk for ERCP-induced pancreatitis. A statistically significant association between obesity and the severity of ERCP-induced pancreatitis was not apparent.
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http://dx.doi.org/10.1097/MCG.0b013e318159cbd1DOI Listing
December 2008

Comparison of secretin-stimulated magnetic resonance pancreatography and manometry results in patients with suspected sphincter of oddi dysfunction.

Acad Radiol 2008 May;15(5):601-9

Department of Radiology, Indiana University School of Medicine, 550 N. University Blvd, Room 0279, Indianapolis, IN, 46202, USA.

Rationale And Objectives: To measure main pancreatic duct diameter (PDD) with magnetic resonance pancreatography (MRP) before and after secretin injection in patients with suspected sphincter of Oddi dysfunction (SOD) and to determine if the diameter change is predictive of sphincter of Oddi manometry (SOM) results.

Materials And Methods: We identified all patients during the study period referred for SOM for clinically suspected SOD; patients with an intact sphincter and without contraindication to MRP examination were considered for study entry. Consenting patients underwent MRP, including dynamic imaging of the pancreatic duct after intravenous administration of porcine secretin followed by SOM during endoscopic retrograde cholangiopancreatography. MRP was defined as abnormal when PDD remained increased by > or = 1.0 mm from baseline 15 minutes after secretin injection. SOM was abnormal when basal sphincter pressure (SP) was > or = 40 mm Hg. Mean PDD before and after secretin administration was compared within normal and abnormal SP groups with two-tailed unpaired t-test; the mean difference between baseline and peak PDD and duration of > or = 0.5 mm increase in PDD was compared between groups with two-tailed t-test. P < .05 was considered significant.

Results: Of 70 patients referred for SOM, 30 met all entry criteria, gave consent to participate, and underwent both MRP and SOM. Ten of 30 patients (33%) had normal SP; 20 (67%) were abnormal. PDD increased significantly after secretin injection (normal SP, 1.62 +/- 0.73 to 2.78 +/- 0.77 mm, P < .01; abnormal SP, 1.45 +/- 0.26 to 2.32 +/- 0.75 mm, P < .01). There was no difference between normal and abnormal SP groups in amount of PDD increase (1.15 +/- 0.75 vs. 0.88 +/- 0.72 mm; P = .33) or duration of > or = 0.5 mm increase in PDD (5.28 +/- 8.76 vs. 13.60 +/- 13.00 minutes; P = 0.07).

Conclusions: In patients with suspected sphincter of Oddi dysfunction, magnetic resonance pancreatography demonstrated PDD increase following secretin injection but did not predict the results of manometry.
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http://dx.doi.org/10.1016/j.acra.2007.12.009DOI Listing
May 2008

Large-diameter biliary orifice balloon dilation to aid in endoscopic bile duct stone removal: a multicenter series.

Gastrointest Endosc 2008 Jun 21;67(7):1046-52. Epub 2008 Feb 21.

Division of Gastroenterology/Hepatology, Indiana University School of Medicine, Indianapolis, Indiana, USA.

Background: The utility and safety of endoscopic biliary orifice balloon dilation (EBD) for bile duct stone removal (with use of large-diameter balloons) after biliary endoscopic sphincterotomy (BES) is currently not well established.

Objective: Our purpose was to evaluate the efficacy and complications of BES followed by > or = 12 mm diameter EBD for bile duct stone removal.

Design: Retrospective, multicenter series.

Setting: Five ERCP referral centers in the United States.

Patients And Interventions: Patients who underwent attempted removal of bile duct stones by BES followed by EBD with > or = 12 mm diameter dilating balloons were identified by searching the prospectively recorded endoscopic databases from 1999 to 2007. Clinical parameters, endoscopic data, and outcomes were collected and analyzed.

Results: One hundred three patients, mean age 70 +/- 17 years (range 23-98 years), with 56 (54%) women, underwent 107 procedures. Eleven patients (11%) had a prior history of acute pancreatitis. Pancreatogram was performed in 15 (14%) patients. Median stone size and median balloon diameter used was 13 mm. Complete stone removal in the first session of EBD was accomplished in 102 (95%) procedures, and mechanical lithotripsy was required in 29 (27%). Six patients (5.4%) had documented procedure-related complications including one patient with severe bleeding and one with severe cystic duct perforation. No acute pancreatitis occurred.

Conclusion: EBD with a large-diameter balloon in conjunction with BES for bile duct stone removal is effective and relatively safe. This technique appears to be a reasonable alternative option when standard BES and basket or balloon sweep are inadequate to remove bile duct stones.
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http://dx.doi.org/10.1016/j.gie.2007.08.047DOI Listing
June 2008

Efficacy of diclofenac in the prevention of post-ERCP pancreatitis in predominantly high-risk patients: a randomized double-blind prospective trial.

Gastrointest Endosc 2007 Dec;66(6):1126-32

Indiana University Medical Center; Indianapolis, Indiana 46202, USA.

Background: Pancreatitis is one of the major complications of ERCP and endoscopic sphincterotomy. It has been shown that nonsteriodal anti-inflammatory drugs are potent inhibitors of phospholipase A(2), activity which is increased in pancreatitis. A previous study showed reduction of post-ERCP pancreatitis with administration of rectal diclofenac.

Objective: The aim of this study was to determine whether prophylactic oral diclofenac will reduce the incidence and the severity of ERCP-induced pancreatitis, especially in high-risk patients.

Design: Single-center, randomized, double-blinded, prospective study.

Setting: Indiana University Medical Center.

Patients: A total of 207 evaluable patients were randomized to receive either diclofenac 50 mg or placebo by mouth 30 to 90 minutes before and 4 to 6 hours after ERCP.

Results: The groups were similar with regard to patient demographics and to patient and procedure risk factors for post-ERCP pancreatitis. The overall incidence of post-ERCP pancreatitis was 16.4%. It occurred in 17 of 102 patients in the control group (16.7%) and in 17 of 105 patients in diclofenac group (16.2%). The pancreatitis was graded mild in 9.8%, moderate in 5.9%, and severe 1.0% of the control group, and mild in 10.5%, moderate in 4.8%, and severe in 1.0% of the diclofenac group. In high-risk patients, the incidence of post-ERCP pancreatitis was 17.3%. It occurred in 18.0% (16/89) in the control group and in 17.8% (16/90) in the diclofenac group. There was no significant difference between the groups in the frequency or severity of post-ERCP pancreatitis in overall and high-risk patients; however, the power of the study was less than 45%.

Conclusions: Prophylactic orally administered diclofenac was not observed to affect the frequency or severity of post-ERCP pancreatitis in high-risk patients.
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http://dx.doi.org/10.1016/j.gie.2007.04.012DOI Listing
December 2007