Publications by authors named "Bertrand Napoleon"

77 Publications

Endoscopic management of superficial nonampullary duodenal tumors: European Society of Gastrointestinal Endoscopy (ESGE) Guideline.

Endoscopy 2021 05 1;53(5):522-534. Epub 2021 Apr 1.

Department of Gastroenterology and Hepatology, Leiden University Medical Center, The Netherlands.

1: ESGE recommends that all duodenal adenomas should be considered for endoscopic resection as progression to invasive carcinoma is highly likely.Strong recommendation, low quality evidence. 2: ESGE recommends performance of a colonoscopy, if that has not yet been done, in cases of duodenal adenoma.Strong recommendation, low quality evidence. 3: ESGE recommends the use of the cap-assisted method when the location of the minor and/or major papilla and their relationship to a duodenal adenoma is not clearly established during forward-viewing endoscopy.Strong recommendation, moderate quality evidence. 4: ESGE recommends the routine use of a side-viewing endoscope when a laterally spreading adenoma with extension to the minor and/or major papilla is suspected.Strong recommendation, low quality evidence. 5: ESGE suggests cold snare polypectomy for small (< 6 mm in size) nonmalignant duodenal adenomas.Weak recommendation, low quality evidence. 6: ESGE recommends endoscopic mucosal resection (EMR) as the first-line endoscopic resection technique for nonmalignant large nonampullary duodenal adenomas.Strong recommendation, moderate quality evidence. 7: ESGE recommends that endoscopic submucosal dissection (ESD) for duodenal adenomas is an effective resection technique only in expert hands.Strong recommendation, low quality evidence. 8: ESGE recommends using techniques that minimize adverse events such as immediate or delayed bleeding or perforation. These may include piecemeal resection, defect closure techniques, noncontact hemostasis, and other emerging techniques, and these should be considered on a case-by-case basis.Strong recommendation, low quality evidence. 9: ESGE recommends endoscopic surveillance 3 months after the index treatment. In cases of no recurrence, a further follow-up endoscopy should be done 1 year later. Thereafter, surveillance intervals should be adapted to the lesion site, en bloc resection status, and initial histological result. Strong recommendation, low quality evidence.
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http://dx.doi.org/10.1055/a-1442-2395DOI Listing
May 2021

Treatment of acute cholecystitis in high-risk surgical patients. Systematic review of the literature according to the levels of evidence.

Minerva Gastroenterol (Torino) 2021 Apr 1. Epub 2021 Apr 1.

Gastroenterology Unit, Department of Medical and Surgical Sciences, Hospital of Imola, University of Bologna, Bologna, Italy.

Acute cholecystitis (AC) is the most common biliary stone disease complication. While there is consensus regarding cholecystectomy for AC, gallbladder drainage is indicated in elderly or high-risk surgical patients. We systematically reviewed available evidence in the field of EUS-guided gallbladder drainage (EUS-GBD) for AC in high-risk surgical patients. The studies were classified according to their level of evidence (LE) according to the Oxford Centre for Evidence Based Medicine classification. Literature search retrieved 175 manuscripts; most of them were expert opinions (LE V, no. 53) or caseseries (LE IV, no. 29). There was no meta-analysis of RCT (LE Ia), while two randomized controlled trials (LE Ib) demonstrated that EUS-GBD was superior to percutaneous trans-hepatic-GBD (PT-GBD) regarding longterm outcomes (adverse events, recurrent cholecystitis, and reintervention). Several meta-analyses of cohort studies (LE IIa, no. 11) were designed to compare the three available drainage strategies (endoscopic, echoendoscopic and percutaneous) and to assess the pooled risk of adverse events. Comparison between surgery and EUS-GBD was done in a single retrospective study with a propensity score analysis (LE III). The outcomes of conversion from PT-GBD to EUS-GBD were covered by few retrospective studies (LE III). Several manuscripts (no. 69) were published on EUS-GBD as a rescue strategy in case of malignant biliary obstruction. The levels of evidence of EUS-GBD in the literature have evolved from initial descriptive studies to recent randomized controlled trials and meta-analysis of cohort studies. While several articles addressed the comparison among different techniques for GBD, in our opinion some topics and questions have not been adequately investigated. are still debated.
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http://dx.doi.org/10.23736/S2724-5985.21.02854-3DOI Listing
April 2021

Endoscopic management of ampullary tumors: European Society of Gastrointestinal Endoscopy (ESGE) Guideline.

Endoscopy 2021 Apr 16;53(4):429-448. Epub 2021 Mar 16.

Department of Gastroenterology and Hepatology, Leiden University Medical Center, The Netherlands.

1: ESGE recommends against diagnostic/therapeutic papillectomy when adenoma is not proven.Strong recommendation, low quality evidence. 2: ESGE recommends endoscopic ultrasound and abdominal magnetic resonance cholangiopancreatography (MRCP) for staging of ampullary tumors.Strong recommendation, low quality evidence. 3: ESGE recommends endoscopic papillectomy in patients with ampullary adenoma without intraductal extension, because of good results regarding outcome (technical and clinical success, morbidity, and recurrence).Strong recommendation, moderate quality evidence. 4: ESGE recommends en bloc resection of ampullary adenomas up to 20-30 mm in diameter to achieve R0 resection, for optimizing the complete resection rate, providing optimal histopathology, and reduction of the recurrence rate after endoscopic papillectomy.Strong recommendation, low quality evidence. 5: ESGE suggests considering surgical treatment of ampullary adenomas when endoscopic resection is not feasible for technical reasons (e. g. diverticulum, size > 4 cm), and in the case of intraductal involvement (of > 20 mm). Surveillance thereafter is still mandatory.Weak recommendation, low quality evidence. 6: ESGE recommends direct snare resection without submucosal injection for endoscopic papillectomy.Strong recommendation, moderate quality evidence. 7: ESGE recommends prophylactic pancreatic duct stenting to reduce the risk of pancreatitis after endoscopic papillectomy.Strong recommendation, moderate quality evidence. 8: ESGE recommends long-term monitoring of patients after endoscopic papillectomy or surgical ampullectomy, based on duodenoscopy with biopsies of the scar and of any abnormal area, within the first 3 months, at 6 and 12 months, and thereafter yearly for at least 5 years.Strong recommendation, low quality evidence.
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http://dx.doi.org/10.1055/a-1397-3198DOI Listing
April 2021

Evaluation of the performances of a single-use duodenoscope: Prospective multi-center national study.

Dig Endosc 2021 Mar 5. Epub 2021 Mar 5.

Centre Hospitalier Universitaire de Nice, Hôpital L'Archet 2, Nice, France.

Objectives: A single-use duodenoscope (SUD) has been recently developed to overcome issues with endoscopic retrograde cholangiopancreatography (ERCP)-related cross-infections. The aim was to evaluate SUD safety and performance in a prospective multi-centre study.

Methods: All consecutive patients undergoing ERCP in six French centers were prospectively enrolled. All procedures were performed with the SUD; in case of ERCP failure, operators switched to a reusable duodenoscope. Study outcomes were the successful completion of the procedure with SUD, safety and operators' satisfaction based on a VAS 0-10 and on 22 qualitative items. The study protocol was approved by French authorities and registered (ID-RCB: 2020-A00346-33). External companies collected the database and performed statistical analysis.

Results: Sixty patients (34 females, median age 65.5 years old) were enrolled. Main indications were bile duct stones (41.7%) and malignant biliary obstruction (26.7%). Most ERCP were considered ASGE grade 2 (58.3%) or 3 (35.0%). Fifty-seven (95.0%) procedures were completed using the SUD. Failures were unrelated to SUD (one duodenal stricture, one ampullary infiltration, and one tight biliary stricture) and could not be completed with reusable duodenoscopes. Median operators' satisfaction was 9 (7-9). Qualitative assessments were considered clinically satisfactory in a median of 100% of items and comparable to a reusable duodenoscope in 97.9% of items. Three patients (5%) reported an adverse event. None was SUD-related.

Conclusions: The use of a SUD allows ERCP to be performed with an optimal successful rate. Our data show that SUD could be used for several ERCP indications and levels of complexity.
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http://dx.doi.org/10.1111/den.13965DOI Listing
March 2021

The Asian Federation of Societies for Ultrasound in Medicine and Biology (AFSUMB) Guidelines for Contrast-Enhanced Endoscopic Ultrasound.

Ultrasound Med Biol 2021 Jun 27;47(6):1433-1447. Epub 2021 Feb 27.

Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.

The Asian Federation of Societies for Ultrasound in Medicine and Biology aimed to provide information on techniques and indications for contrast-enhanced harmonic endoscopic ultrasound (CH-EUS), and to create statements including the level of recommendation. These statements are based on current scientific evidence reviewed by a Consensus Panel of 15 internationally renowned experts. The reliability of clinical questions was measured by agreement rates after voting. Six statements were made on techniques, including suitable contrast agents for CH-EUS, differences between contrast agents, setting of mechanical index, dual imaging and duration and phases for observation. Thirteen statements were made on indications, including pancreatic solid masses, pancreatic cancer staging, pancreatic cystic lesions and mural nodules, detection of subtle pancreatic lesions, gallbladder sludge and polyps, hepatic lesions, lymph nodes, subepithelial lesions, visceral vascular diseases, guidance of fine needle aspiration and evaluation for local therapy. These international expert consensus guidelines will assist endosonographers in conducting CH-EUS according to evidence-based information.
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http://dx.doi.org/10.1016/j.ultrasmedbio.2021.01.030DOI Listing
June 2021

Confocal endomicroscopy for evaluation of pancreatic cystic lesions: a systematic review and international Delphi consensus report.

Endosc Int Open 2020 Nov 22;8(11):E1566-E1581. Epub 2020 Oct 22.

Division of Gastroenterology Mount Auburn Hospital Cambridge, Massachusetts, United States.

The aim of thi systematic review and consensus report is to standardize the practice of endoscopic ultrasound (EUS-guided needle-based confocal laser endomicroscopy (nCLE) for pancreatic cystic lesion (PCL) evaluation. We performed an international, systematic, evidence-based review of the applications, outcomes, procedural processes, indications, training, and credentialing of EUS-nCLE in management of PCLs. Based on available clinical evidence, preliminary nCLE consensus statements (nCLE-CS) were developed by an international panel of 15 experts in pancreatic diseases. These statements were then voted and edited by using a modified Delphi approach. An a priori threshold of 80 % agreement was used to establish consensus for each statement. Sixteen nCLE-CS were discussed. Thirteen (81 %) nCLE-CS reached consensus addressing indications (non-communication PCL meeting criteria for EUS-FNA or with prior non-diagnostic EUS-FNA), diagnostic outcomes (improved accuracy for mucinous PCLs and serous cystadenomas with substantial interobserver agreement of image patterns), low incidence of adverse events (fluorescein-associated and pancreatitis), procedural processes (nCLE duration, manipulation of needle with probe), and training (physician knowledge and competence). Based on a high level of agreement pertaining to expert consensus statements, this report standardizes the practice of EUS-nCLE. EUS-nCLE should be systematically considered when EUS-FNA is indicated for PCL evaluation.
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http://dx.doi.org/10.1055/a-1229-4156DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7581463PMC
November 2020

Performance of digital single-operator cholangiopancreatoscope for biliopancreatic diseases in real life: results from a prospective multicenter study.

Scand J Gastroenterol 2020 Nov 23;55(11):1381-1388. Epub 2020 Oct 23.

Department of Hepatogastroenterology, Hôpital Privé Jean Mermoz, Lyon, France.

Objectives: Peroralcholangio-pancreatoscopy (POCP) is used for diagnosis and treatment of biliopancreatic disease when standard endoscopy (ERCP) or pre-operative imaging workup failed. We aimed to evaluate the diagnostic and therapeutic performance of POCP in complex biliary and pancreatic diseases.

Materials And Methods: Patients with indeterminate biliary or pancreatic duct (PD) strictures, and patients with failure of complex biliary or pancreatic stones removal, were enrolled (six centers). The primary endpoint evaluated malignancy diagnostic performances (accuracy, sensitivity, specificity) and therapeutic performances (biliary or pancreatic stones extraction). Secondary endpoints evaluated: technical success in lesion visualization, ease of maneuvering, image quality and 30-days complications.

Results: From November 2016 to March 2018, 66 patients were included: 29/37 women/men, median age (IQR): 73 (64-82). Fifty-three patients had diagnostic POCP and 13 patients therapeutic POCP. One endoscopist with one or two endoscopy nurses performed 94% of the POCP. The 'POCP visual impression' of malignancy showed 92.0% sensitivity, 92.9 % specificity and 92.5 % overall accuracy compared with the final diagnosis. 'POCP-guided samples histological analysis' showed 75.0 % sensitivity and 91.6% specificity. The technical success for lesion visualization was 98.5%. The median VAS scores for insertions in bile and PD were respectively 9.0 (8.1-9.6) and 9.0 (8.8-10.0). Median VAS score for access to the lesion and image quality were respectively 9.0 (7.7-9.6) and 9.0 (7.9-9.7). Only three 30-day minor complications occurred without any major complications.

Conclusions: POCP was an effective, safe and easy-to-use tool in routine clinical practice for the management of complex diagnostic and therapeutic biliary and pancreatic diseases (NCT03190343).
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http://dx.doi.org/10.1080/00365521.2020.1832143DOI Listing
November 2020

How to perform EUS-guided tattooing?

Endosc Ultrasound 2020 Sep-Oct;9(5):291-297

Department Allgemeine Innere Medizin, Kliniken Hirslanden, Beau Site, Salem und Permanence, Bern, Switzerland.

Recently, we introduced a series of papers describing on how to perform certain techniques and controversies in EUS. In the first paper, "What should be known before performing EUS examinations, Part I," the authors discussed clinical information and whether other imaging modalities should be needed before embarking in EUS examination. In Part II, some technical controversies on how EUS is performed are discussed from different points of view by providing the relevant available evidence. Herewith, we describe on how to perform EUS-guided fine needle tattooing (FNT) in daily practice. The aim of this paper is to discuss pros and cons for several issues including historical remarks, injecting material, technical approach, and how to perform EUS-FNT including argues in favor and against.
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http://dx.doi.org/10.4103/eus.eus_44_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7811726PMC
September 2020

Risk Assessment of Pancreatic Cysts: Benign and Malign Entwined.

Dig Dis Sci 2020 Aug 24. Epub 2020 Aug 24.

Department of Gastroenterology, Ramsay Générale de Santé Private Hospital Jean Mermoz, 69008, Lyon, France.

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http://dx.doi.org/10.1007/s10620-020-06555-1DOI Listing
August 2020

Do we need elastography for EUS?

Endosc Ultrasound 2020 Sep-Oct;9(5):284-290

Department of Internal Medicine, Krankenhaus Märkisch Oderland Strausberg/Wriezen; Brandenburg Institute of Clinical Ultrasound, Medical University Brandenburg, Neuruppin, Germany.

We recently introduced a series of papers "What should be known prior to performing EUS exams." In Part I, the authors discussed which clinical information and whether other imaging modalities are needed before embarking EUS examinations. In Part II, technical controversies on how EUS is performed were discussed from different points of view. In this article, important practical issues regarding EUS elastography will be raised and controversially discussed from very different points of view.
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http://dx.doi.org/10.4103/eus.eus_25_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7811716PMC
July 2020

Do we need contrast agents for EUS?

Endosc Ultrasound 2020 Nov-Dec;9(6):361-368

Johann Wolfgang Goethe University Frankfurt, Germany; Department of Medical Ultrasound, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, Hubei, China; Department Allgemeine Innere Medizin, Kliniken Hirslanden, Beau Site, Salem und Permanence, Bern, Switzerland.

We recently introduced a series of articles that dealt with controversies in EUS. In Part I, the authors discussed which clinical information is necessary prior to EUS and whether other imaging modalities are required before embarking on EUS examinations. Part II focuses on technical details and controversies about the use of EUS in special situations. In this article, important practical issues regarding the application of contrast-enhanced EUS in various clinical settings are raised and controversially discussed from different points of view.
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http://dx.doi.org/10.4103/eus.eus_20_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7811706PMC
July 2020

Pancreaticoduodenectomy following endoscopic ultrasound-guided choledochoduodenostomy with electrocautery-enhanced lumen-apposing stents an ACHBT - SFED study.

HPB (Oxford) 2021 Jan 6;23(1):154-160. Epub 2020 Jul 6.

Service de Gastroentérologie, Hopital Privé Jean Mermoz, Ramsay Générale de Santé, Lyon, France.

Background: After ERCP failure or if ERCP is declined for preoperative biliary drainage before pancreaticoduodenectomy, endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) with electrocautery-enhanced lumen-apposing stents (ECE-LAMS) might be needed. The aim of the present study was to assess the technical feasibility and short-term outcomes of pancreaticoduodenectomy (PD) following endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) with electrocautery-enhanced lumen-apposing stents (ECE-LAMS).

Methods: A retrospective study of all EUS-CDS procedures with ECE-LAMS followed by PD performed in France since the availability of the device in 2016.

Results: 21 patients underwent PD in 9 departments of surgery following EUS-CDS with ECE-LAMS. The median bilirubin level at endoscopic procedure was 292 μmol/L. A 6 mm diameter stent was used in 20 cases. No complications occurred during the procedure. During the waiting time, 1 patient had an acute pancreatitis post ERCP and 3 patients developed cholangitis, treated by either an additional percutaneous biliary drainage, or an endoscopic procedure to extract a bezoar occluding the stent, or antibiotics, respectively. PD with a curative intent was performed in all cases. Overall, postoperative mortality was nil and postoperative morbidity occurred in 17 patients (81%), including 3 with severe complications (14%). No patient developed postoperative biliary fistula. In the 21 patients followed at least 6 months, no biliary complications occurred, and no tumor recurrence developed on the hepaticojejunostomy/hepatic pedicle.

Conclusion: Pancreaticoduodenectomy following EUS-CDS with ECE-LAMS is technically feasible with acceptable short-term postoperative outcome, including healing of biliary anastomosis.
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http://dx.doi.org/10.1016/j.hpb.2020.06.001DOI Listing
January 2021

22G Acquire vs. 20G Procore needle for endoscopic ultrasound-guided biopsy of pancreatic masses: a randomized study comparing histologic sample quantity and diagnostic accuracy.

Endoscopy 2020 09 14;52(9):747-753. Epub 2020 May 14.

Digestive Endoscopy Unit, Hôpital Privé Jean Mermoz, Ramsay Générale de Santé, Lyon, France.

BACKGROUND : Endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) has been suggested for obtaining high quality tissue samples from pancreatic tumors. We performed a multicenter randomized crossover trial comparing EUS-FNB with a 20G Procore needle vs. a 22G Acquire needle. The aims were to compare the quantity of targeted tissue (pancreas) and diagnostic accuracy for the two needles. METHODS : 60 patients admitted for EUS-FNB in three endoscopy units were included. One pass was performed consecutively with each needle, in a randomized order. Histologic material was studied in a blinded manner with respect to the needle. The primary end point was mean cumulative length of tissue core biopsies per needle pass. RESULTS : Final diagnosis was adenocarcinoma (n = 46; 77 %), neuroendocrine neoplasm (n = 11; 18 %), autoimmune pancreatitis (n = 2), and mass-forming chronic pancreatitis (n = 1). The mean cumulative length of tissue core biopsies per needle pass was significantly higher with the 22G Acquire needle at 11.4 mm (95 % confidence interval [CI] 9.0 - 13.8] vs. 5.4 mm (95 %CI 3.8 - 7.0) for the 20G Procore needle ( < 0.001), as was the mean surface area (3.5 mm [95 %CI 2.7 - 4.3] vs. 1.8 mm [95 %CI 1.2 - 2.3];  < 0.001). Diagnostic adequacy and accuracy were 100 % and 87 % with the 22G Acquire needle, and 82 % and 67 % with the 20G Procore needle ( = 0.001 and  = 0.02, respectively). CONCLUSIONS : EUS-guided biopsy of pancreatic masses with the 22G Acquire needle provided more tissue for histologic evaluation and better diagnostic accuracy than the 20G Procore needle.
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http://dx.doi.org/10.1055/a-1160-5485DOI Listing
September 2020

A New Score to Predict the Resectability of Pancreatic Adenocarcinoma: The BACAP Score.

Cancers (Basel) 2020 Mar 25;12(4). Epub 2020 Mar 25.

The Digestive Surgery and Liver Transplantation Department, Toulouse University Hospital, 31400 Toulouse, France.

Surgery remains the only curative treatment for pancreatic ductal adenocarcinoma (PDAC). Therefore, a predictive score for resectability on diagnosis is needed. A total of 814 patients were included between 2014 and 2017 from 15 centers included in the BACAP (the national Anatomo-Clinical Database on Pancreatic Adenocarcinoma) prospective cohort. Three groups were defined: resectable (Res), locally advanced (LA), and metastatic (Met). Variables were analyzed and a predictive score was devised. Of the 814 patients included, 703 could be evaluated: 164 Res, 266 LA, and 273 Met. The median ages of the patients were 69, 71, and 69, respectively. The median survival times were 21, 15, and nine months, respectively. Six criteria were significantly associated with a lower probability of resectability in multivariate analysis: venous/arterial thrombosis ( = 0.017), performance status 1 ( = 0.032) or ≥ 2 ( = 0.010), pain ( = 0.003), weight loss ≥ 8% ( = 0.019), topography of the tumor (body/tail) ( = 0.005), and maximal tumor size 20-33 mm ( < 0.013) or >33 mm ( < 0.001). The BACAP score was devised using these criteria (http://jdlp.fr/resectability/) with an accuracy of 81.17% and an area under the receive operating characteristic (ROC) curve of 0.82 (95% confidence interval (CI): 0.78; 0.86). The presence of pejorative criteria or a BACAP score < 50% indicates that further investigations and even neoadjuvant treatment might be warranted. Trial registration: NCT02818829.
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http://dx.doi.org/10.3390/cancers12040783DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7226323PMC
March 2020

EUS-guided choledochoduodenostomy by use of electrocautery-enhanced lumen-apposing metal stents: a French multicenter study after implementation of the technique (with video).

Gastrointest Endosc 2020 07 19;92(1):134-141. Epub 2020 Feb 19.

service d'Hépato-gastro-entérologie, Hopital Privé Jean Mermoz, Lyon, France.

Background And Aims: EUS-guided biliary drainage is indicated in cases of impossibility or failure of classic biliary drainage by ERCP. Recently we reported good efficiency of EUS-guided choledochoduodenostomy (EUS-CDS) using the electrocautery-enhanced lumen-apposing metal stent (ECE-LAMS) in a retrospective multicenter study. Use of the recommended technique (direct puncture with the ECE-LAMS with use of a pure cut current and a 6-mm stent) was the only predictive factor of clinical success. We re-evaluated this procedure after 1 year in the same centers.

Methods: This was a French retrospective multicenter study of a prospective database including all cases of EUS-guided CDS with ECE-LAMS in the 7 centers that participated in the first study.

Results: Seventy consecutive patients were included in this study between September 1, 2017, and September 22, 2018. Failure of primary ERCP was due to duodenal stenosis in 44% of cases and to tumoral infiltration of the papilla in 22% of cases. The mean duration of the procedure was 5 ± 3 minutes. The recommended technique was used in 98.5% of cases. The technical and clinical success rates were both 97.1% (69/70). Short-term adverse events (periprocedural and intrahospital) occurred in 1.6%.

Conclusions: EUS-CDS with the ECE-LAMS is efficacious and safe in distal malignant obstruction of the common bile duct in cases of ERCP failure with impressive results once expertise is acquired and the recommended technique (direct fistulotomy, pure cut current, and 6-mm stent) is followed.
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http://dx.doi.org/10.1016/j.gie.2020.01.055DOI Listing
July 2020

EUS-specific stents: Available designs and probable lacunae.

Endosc Ultrasound 2019 Nov 28;8(Suppl 1):S17-S27. Epub 2019 Nov 28.

Department of Hepato-Gastroenterology, Ramsay Private Hospital Jean-Mermoz, Lyon, France.

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http://dx.doi.org/10.4103/eus.eus_50_19DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6896438PMC
November 2019

Genomic profile concordance between pancreatic cyst fluid and neoplastic tissue.

World J Gastroenterol 2019 Sep;25(36):5530-5542

Aix-Marseille Univ, INSERM, MMG, Marseille 13385, France.

Background: DNA mutational analysis of pancreatic cystic fluid (CF) is a useful adjunct to the evaluation of pancreatic cysts. KRAS/GNAS or RAF/PTPRD/CTNNB1/RNF43 mutations are highly specific to precancerous or advanced neoplasia. Several studies recently demonstrated the ability of next-generation sequencing (NGS) analysis to detect DNA mutations in pancreatic CF, but few studies have performed a systematic comparative analysis between pancreatic CF and neoplastic surgical tissue (NT). The value of CF-NGS analysis indicators for determining surgical resection necessitates evaluation.

Aim: To confirm whether CF genomic profiles are a reliable malignancy predictor by comparing NGS mutational analyses of CF and NT.

Methods: Patients requiring surgery for high-risk pancreatic cysts were included in a multicenter prospective pilot study. DNA from CF (collected by endoscopic ultrasound-guided fine needle aspiration (known as EUS-FNA)) and NT (collected by surgery) were analyzed by NGS. The primary objective was to compare the mutation profiles of paired DNA samples. The secondary objective was to correlate the presence of specific mutations (KRAS/GNAS, RAF/ PTPRD/CTNNB1/RNF43/POLD1/TP53) with a final cancer diagnosis. Sensitivity and specificity were also evaluated.

Results: Between December 2016 and October 2017, 20 patients were included in this pilot study. Surgery was delayed for 3 patients. Concordant CF-NT genotypes were found in 15/17 paired DNA, with a higher proportion of mutated alleles in CF than in NT. NGS was possible for all pancreatic CF collected by EUS-FNA. In 2 cases, the presence of a KRAS/GNAS mutation was discordant between CF and NT. No mutations were found in 3 patients with NT or pancreatic cysts with high-grade dysplasia. The sensitivity and specificity of KRAS/GNAS mutations in CF to predict an appropriate indication for surgical resection were 0.78 and 0.62, respectively. The sensitivity and specificity of RAF/PTPRD/CTNNB1 /RNF43/POLD1/TP53 mutations in CF were 0.55 and 1.0, respectively.

Conclusion: Mutational analyses of CF and NT were highly concordant, confirming the value of NGS analysis of CF in the preoperative malignancy assessment. However, these results need to be confirmed on a larger scale.
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http://dx.doi.org/10.3748/wjg.v25.i36.5530DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6767987PMC
September 2019

What should be known prior to performing EUS exams? (Part II).

Endosc Ultrasound 2019 Nov-Dec;8(6):360-369

Division of Gastroenterology, Endosonography and Advanced Therapeutic Endoscopy, The American University of Beirut, Medical Center, Beirut, Lebanon.

In "What should be known prior to performing EUS exams, Part I," the authors discussed the need for clinical information and whether other imaging modalities are required before embarking EUS examinations. Herewith, we present part II which addresses some (technical) controversies how EUS is performed and discuss from different points of view providing the relevant evidence as available. (1) Does equipment design influence the complication rate? (2) Should we have a standardized screen orientation? (3) Radial EUS versus longitudinal (linear) EUS. (4) Should we search for incidental findings using EUS?
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http://dx.doi.org/10.4103/eus.eus_57_19DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6927139PMC
October 2019

EUS-guided confocal laser endomicroscopy: prediction of dysplasia in intraductal papillary mucinous neoplasms (with video).

Gastrointest Endosc 2020 03 19;91(3):551-563.e5. Epub 2019 Sep 19.

Division of Gastroenterology, Hepatology and Nutrition, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.

Background And Aims: Previous studies have validated EUS-guided needle-based confocal laser endomicroscopy (nCLE) diagnosis of intraductal papillary mucinous neoplasms (IPMNs). We sought to derive EUS-guided nCLE criteria for differentiating IPMNs with high-grade dysplasia/adenocarcinoma (HGD-Ca) from those with low/intermediate-grade dysplasia (LGD).

Methods: We performed a post hoc analysis of consecutive IPMNs with a definitive diagnosis from a prospective study evaluating EUS-guided nCLE in the diagnosis of pancreatic cysts. Three internal endosonographers reviewed all nCLE videos for the patients and identified potential discriminatory EUS-guided nCLE variables to differentiate HGD-Ca from LGD IPMNs (phase 1). Next, an interobserver agreement (IOA) analysis of variables from phase 1 was performed among 6 blinded external nCLE experts (phase 2). Last, 7 blinded nCLE-naïve observers underwent training and quantified variables with the highest IOA from phase 2 using dedicated software (phase 3).

Results: Among 26 IPMNs (HGD-Ca in 16), the reference standard was surgical histopathology in 24 and cytology confirmation of metastatic liver lesions in 2 patients. EUS-guided nCLE characteristics of increased papillary epithelial "width" and "darkness" were the most sensitive variables (90%; 95% confidence interval [CI], 84%-94% and 91%; 95% CI, 85%-95%, respectively) and accurate (85%; 95% CI, 78%-90% and 84%; 95% CI, 77%-89%, respectively) with substantial (κ = 0.61; 95% CI, 0.51-0.71) and moderate (κ = 0.55; 95% CI, 0.45-0.65) IOAs for detecting HGD-Ca, respectively (phase 2). Logistic regression models were fit for the outcome of HGD-Ca as predictor variables (phase 3). For papillary width (cut-off ≥50 μm), the sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) for detection of HGD-Ca were 87.5% (95% CI, 62%-99%), 100% (95% CI, 69%-100%), and 0.95, respectively. For papillary darkness (cut-off ≤90 pixel intensity), the sensitivity, specificity, and AUC for detection of HGD-Ca were 87.5% (95% CI, 62%-99%), 100% (95% CI, 69%-100%), and 0.90, respectively.

Conclusions: In this derivation study, quantification of papillary epithelial width and darkness identified HGD-Ca in IPMNs with high accuracy. These quantifiable variables can be used in multicenter studies for risk stratification of IPMNs. (Clinical trial registration number: NCT02516488.).
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http://dx.doi.org/10.1016/j.gie.2019.09.014DOI Listing
March 2020

Impact of needle-based confocal laser endomicroscopy on the therapeutic management of single pancreatic cystic lesions.

Surg Endosc 2020 06 13;34(6):2532-2540. Epub 2019 Aug 13.

Hôpital Privé Jean Mermoz, Ramsay Générale de Santé, 4 rue Jacqueline Auriol, 69008, Lyon, France.

Background And Aim: The diagnosis and therapeutic management of large single pancreatic cystic lesions (PCLs) represent major issues for clinicians and essentially rely on endoscopic ultrasound fine-needle aspiration (EUS-FNA) findings. Needle-based confocal laser endomicroscopy (nCLE) has high diagnostic performance for PCLs. This study aimed to evaluate the impact of nCLE on the therapeutic management of patients with single PCLs.

Methods: Retrospective and comparative study. Five independent pancreatic disease experts from tertiary hospitals independently reviewed data from a prospective database of 206 patients with single PCL, larger than 2 cm and who underwent EUS-FNA and nCLE. Two evaluations were performed. The first one included the sequential review of clinical information, EUS report and FNA results. The second one included the same data + nCLE report. Participants had to propose a therapeutic management for each case.

Results: The addition of nCLE to EUS-FNA led to significant changes in therapeutic management for 28% of the patients (p < 0.001). nCLE significantly increased the interobserver agreement of 0.28 (p < 0.0001), from 0.36 (CI 95% 0.33-0.49) to 0.64 (CI 95% 0.61-0.67). nCLE improved the rates of full agreement among the five experts of 24% (p < 0.0001), from 30 to 54%. With nCLE, the surveillance rate of benign SCAs fell by 35%, from 40 (28/70) to 5% (4/76).

Conclusion: The addition of nCLE to EUS-FNA significantly improves reliability of PCL diagnosis and could impact the therapeutic management of patients with single PCLs. ClinicalTrials.gov number, NCT01563133.
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http://dx.doi.org/10.1007/s00464-019-07062-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7214514PMC
June 2020

Endoscopic ultrasound-guided biliary drainage: A change in paradigm?

World J Gastrointest Endosc 2019 May;11(5):345-353

Department of Gastroenterology, Jean Mermoz Private Hospital, 55 avenue Jean Mermoz, Lyon 69008, France.

Endoscopic ultrasound-guided biliary drainage (EUS-BD) has been developed as an alternative means of biliary drainage for malignant biliary obstruction (MBO). Compared to percutaneous transhepatic biliary drainage, EUS-BD offers effective internal drainage in a single session in the event of failed endoscopic retrograde cholangiopancreatography and has fewer adverse events (AE). In choosing which technique to use for EUS-BD, a combination of factors appears to be important in decision-making; technical expertise, the risk of AE, and anatomy. With the advent of novel all-in-one EUS-BD specific devices enabling simpler and safer techniques, as well as the growing experience and training of endosonographers, EUS-BD may potentially become a first-line technique in biliary drainage for MBO.
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http://dx.doi.org/10.4253/wjge.v11.i5.345DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6556485PMC
May 2019

What should be known prior to performing EUS?

Endosc Ultrasound 2019 Jan-Feb;8(1):3-16

Endosonography and advanced therapeutic endoscopy, Division of Gastroenterology, The American University of Beirut, Medical Center, Beirut, Lebanon.

Direct referral of patients for EUS - instead of preprocedural consultation with the endosonographer - has become standard practice (like for other endoscopic procedures) as it is time- and cost-effective. To ensure appropriate indications and safe examinations, the endosonographer should carefully consider what information is needed before accepting the referral. This includes important clinical data regarding relevant comorbidities, the fitness of the patient to consent and undergo the procedure, and the anticoagulation status. In addition, relevant findings from other imaging methods to clarify the clinical question may be necessary. Appropriate knowledge and management of the patients' anticoagulation and antiplatelet therapy, antibiotic prophylaxis, and sedation issues can avoid unnecessary delays and unsafe procedures. Insisting on optimal preparation, appropriate indications, and clear clinical referral questions will increase the quality of the outcomes of EUS. In this paper, important practical issues regarding EUS preparations are raised and discussed from different points of view.
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http://dx.doi.org/10.4103/eus.eus_54_18DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6400085PMC
February 2019

Macroscopic onsite evaluation using endoscopic ultrasound fine needle biopsy as an alternative to rapid onsite evaluation.

Endosc Int Open 2019 Feb 18;7(2):E189-E194. Epub 2019 Jan 18.

Department of Gastroenterology, Ramsay Générale de Santé, Hôpital Privé Jean Mermoz, Lyon, France.

 This study aimed to evaluate the performance of Macroscopic On-site Evaluation (MOSE) using a novel endoscopic ultrasound (EUS) fine needle biopsy (FNB) needle (22-G Franseen-tip needle, Acquire, Boston Scientific Incorporated, Boston, Massachusetts, United States), and without using Rapid On-Site Evaluation (ROSE).  Between May 2016 and August 2016, all consecutive patients referred to our center for EUS tissue acquisition (TA) for solid lesions underwent EUS-FNB with the 22-G Franseen-tip needle unless contra-indicated. The operator performed MOSE. If no macroscopic core was visualized, a second pass was performed. The final diagnosis was defined as unequivocal histology from EUS-TA with compatible 18 months follow-up, surgical resection, or both. We retrospectively analyzed the performance of MOSE.  A total of 46 consecutive patients was included, and 54 solid lesions were biopsied. The endosonographer visualized core tissue in 93 % (50/54) of targets with a single pass, of which the pathologist confirmed histologic core fragments in 94 % (47/50). Four lesions required two passes, and the overall correlation between MOSE and histologic core fragments was 94 % (48/51). Diagnostic adequacy was 98 % (53/54) with one biliary target biopsied without significant material. The overall diagnostic accuracy was 94 %. Sensitivity, specificity, positive predictive value, and negative predictive value for malignancy were 92 %, 100 %, 100 %, and 81 %, respectively. No adverse events were reported.  Our study demonstrated that MOSE using the 22-G Franseen-tip needle could limit needle passes by accurately estimating histologic core fragments. It also demonstrated that high diagnostic adequacy and accuracy of > 90 % could be achieved without ROSE.
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http://dx.doi.org/10.1055/a-0770-2726DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6338542PMC
February 2019

Endoscopic ultrasound-guided radiofrequency ablation for pancreatic neuroendocrine tumors and pancreatic cystic neoplasms: a prospective multicenter study.

Endoscopy 2019 09 22;51(9):836-842. Epub 2019 Jan 22.

Aix Marseille Université, Service de Gastro-entérologie, Hôpital Nord, Marseille, France.

Background: Pancreatic neuroendocrine tumors (NETs) and intraductal pancreatic mucinous neoplasia (IPMN) with worrisome features are surgically managed. Endoscopic ultrasound (EUS)-guided radiofrequency ablation (RFA) has recently been developed. The safety of EUS-RFA was the primary end point of this study, its efficacy the secondary end point.

Methods: This was a prospective multicenter study that was planned to include 30 patients with a 1-year follow-up with either a NET < 2 cm or a pancreatic cystic neoplasm (PCN), either a branch duct IPMN with worrisome features or a mucinous cystadenoma (MCA). EUS-RFA was performed with an 18G RFA cooling needle.

Results: 12 patients had 14 NETs (mean size 13.1 mm, range 10 - 20 mm); 17 patients had cystic tumors (16 IPMNs, 1 MCA; mean size 28 mm, range 9 - 60 mm). Overall three adverse events occurred (10 %), two of these in the first two patients (one pancreatitis, one small-bowel perforation). After these initial patients, modifications in the protocol resulted in a decrease in complications (3.5 %), with one patient having a pancreatic ductal stenosis. Among the 14 NETs, at 1-year follow-up 12 had completely disappeared (86 % tumor resolution), with three patients having a delayed response. Among the 17 PCNs, at 12 months, there were 11 complete disappearances and one diameter that decreased by > 50 % (significant response rate 71 %). All 12 mural nodules showed complete resolution.

Conclusions: EUS-RFA of pancreatic NETs or PCNs is safe with a 10 % complication rate, which can be decreased by improved prophylaxis for the procedure.
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http://dx.doi.org/10.1055/a-0824-7067DOI Listing
September 2019

19 G nitinol needle versus 22 G needle for transduodenal endoscopic ultrasound-guided sampling of pancreatic solid masses: a randomized study.

Endoscopy 2019 05 19;51(5):436-443. Epub 2018 Nov 19.

Hepatogastroenterology Department, Hôpital Saint Joseph, Marseille, France.

Background: The aim of this prospective multicenter study was to compare a flexible 19 G needle with nitinol shaft (19 G Flex) with a standard 22 G needle for transduodenal endoscopic ultrasound (EUS)-guided sampling of pancreatic head tumors.

Methods: Patients with pancreatic head tumors requiring tissue diagnosis were randomized into two arms: puncture with either a 19 G Flex needle or a 22 G needle. The primary end point was diagnostic accuracy for malignancy. The secondary end points were ergonomic scores, sample cytohistological quality, and complications. A 6-month follow-up was performed.

Results: 125 patients were randomized and 122 were analyzed: 59 patients in the 19 G Flex arm and 63 patients in the 22 G arm. The final diagnosis was malignancy in 111 patients and benign condition in 11. In intention-to-treat analysis, the diagnostic accuracy for malignancy of the 19 G Flex and 22 G needles was 69.5 % (95 % confidence interval [CI] 56.1 % - 80.8 %) vs. 87.3 % (95 %CI 76.5 % - 94.4 %), respectively ( = 0.02). In per-protocol analysis excluding eight technical failures in the 19 G Flex group, the diagnostic accuracy of the 19 G Flex and 22 G needles was not statistically different: 80.4 % (95 %CI 66.9 % - 90.2 %) vs. 87.3 % (95 %CI 76.5 % - 94.4 %;  = 0.12). Technical success was higher in the 22 G arm than in the 19 G Flex arm: 100 % (95 %CI 94.3 % - 100 %) vs. 86.4 % (95 %CI 75.0 % - 94.0 %), respectively ( = 0.003). Transduodenal EUS-guided sampling was more difficult with the 19 G Flex (odds ratio 0.68, 95 %CI 0.47 - 0.97). CONCLUSION : The 19 G Flex needle was inferior to a standard 22 G needle in diagnosing pancreatic head cancer and more difficult to use in the transduodenal approach.
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http://dx.doi.org/10.1055/a-0757-7714DOI Listing
May 2019

Cholangioscopic diagnostic classification of bile duct lesions: a worthwhile task, not an easy one.

Endoscopy 2018 11 6;50(11):1049-1050. Epub 2018 Nov 6.

Gastroenterology, Jean Mermoz Hospital, Lyon, Ramsay Générale de Santé, France.

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http://dx.doi.org/10.1055/a-0725-8113DOI Listing
November 2018

Needle-based confocal laser endomicroscopy of pancreatic cystic lesions: a prospective multicenter validation study in patients with definite diagnosis.

Endoscopy 2019 09 22;51(9):825-835. Epub 2018 Oct 22.

Unité d'Échoendoscopie et d'Endoscopie d'Oncologie Digestive, Institut Paoli Calmettes, Marseille, France.

Background: Needle-based confocal laser endomicroscopy (nCLE) enables observation of the inner wall of pancreatic cystic lesions (PCLs) during an endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA). This study prospectively evaluated the diagnostic performance of nCLE for large, single, noncommunicating PCLs using surgical histopathology or EUS-FNA cytohistopathology as a reference diagnosis.

Methods: From April 2013 to March 2016, consecutive patients referred for EUS-FNA of indeterminate PCLs without evidence of malignancy or chronic pancreatitis were prospectively enrolled at five centers. EUS-FNA and nCLE were performed and cystic fluid was aspirated for cytohistopathological and carcinoembryonic antigen (CEA) analysis. The diagnostic performance of nCLE was assessed against the reference standard and compared with that of EUS and CEA. This study was registered on ClinicalTrials.gov (NCT01563133).

Results: 206 patients underwent nCLE and 78 PCLs (mean size 40 mm, range 20 - 110 mm) had reference diagnoses (53 premalignant and 25 benign PCLs). Post-procedure pancreatitis occurred in 1.3 % of the patients. nCLE was conclusive in 71 of the 78 cases (91 %). The sensitivies and specifities of nCLE for the diagnosis of serous cystadenoma, mucinous PCL, and premalignant PCL were all ≥ 0.95 (with 95 % confidence interval from 0.85 to 1.0). The AUROC was significantly larger for nCLE than for CEA or EUS.

Conclusions: nCLE had excellent diagnostic performance that surpassed that of CEA and EUS for the diagnosis of large, single, noncommunicating PCLs. The nCLE procedure should be considered in patients with indeterminate PCLs to ensure a more specific diagnosis.
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http://dx.doi.org/10.1055/a-0732-5356DOI Listing
September 2019

Endoscopic ultrasound-guided choledochoduodenostomy with electrocautery-enhanced lumen-apposing stents: a retrospective analysis.

Endoscopy 2019 06 22;51(6):540-547. Epub 2018 Oct 22.

Service d'Hépato-gastro-entérologie, Hopital Privé Jean Mermoz, Lyon, Farnce.

Background: Endoscopic ultrasound-guided biliary drainage is an alternative to percutaneous biliary drainage in cases of malignant biliary obstruction and failure of classic endoscopic drainage by endoscopic retrograde cholangiopancreatography (ERCP). Recently, a new electrocautery-enhanced lumen-apposing metal stent (ECE-LAMS) that allows for endoscopic anastomosis (apposition stent) has become available for use in EUS-choledochoduodenostomy (EUS-CDS) and facilitates the procedure.

Methods: This was a retrospective study of all EUS-CDS procedures performed in France between April 2016 and August 2017. The primary end point was the technical and clinical success rates of EUS-CDS using an ECE-LAMS.

Results: 52 consecutive patients were included in the study. The etiology of distal bile duct obstruction was distal pancreatic adenocarcinoma in 43 patients (82.7 %). The technical success rate was 88.5 % (46 /52 patients), and the clinical success rate was 100 % (46/46 patients). The mean duration of the procedure was 10.2 minutes (range 1 - 90). Two patients (3.8 %) presented with short-term complications after EUS-CDS and before discharge from hospital. In univariate analyses, a small diameter of the common bile duct and not following the recommended procedure technique were significant risk factors for technical failure. Over a mean follow-up of 157 days, the median survival time without biliary complications was 135 days.

Conclusion: EUS-CDS with an ECE-LAMS is efficacious and safe in distal malignant obstruction of the common bile duct and could be proposed as the first option in cases of ERCP failure.
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http://dx.doi.org/10.1055/a-0735-9137DOI Listing
June 2019

Value of contrast-enhanced harmonic endoscopic ultrasonography with enhancement pattern for diagnosis of pancreatic cancer: A meta-analysis.

Dig Endosc 2019 Mar 15;31(2):125-133. Epub 2019 Jan 15.

Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.

Background: Current imaging modalities are limited in their ability to distinguish pancreatic cancer (PC) from non-neoplastic pancreatic lesions. The diagnostic use of contrast-enhanced endoscopic ultrasonography (CE-EUS) has increased, and its utility has been reported. Recently, contrast-enhanced harmonic EUS (CH-EUS) was reported to facilitate imaging of parenchymal perfusion and microvessels in pancreatobiliary diseases, leading to a high diagnostic accuracy for PC. The present meta-analysis aims to investigate the usefulness of CH-EUS with enhancement pattern for PC diagnosis.

Methods: A systematic meta-analysis of all potentially relevant articles identified in PubMed, the Cochrane library, and Medline was carried out. Fixed-effects or random-effects models were used to investigate pooled sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio with 95% confidence interval (CI).

Results: The study enrolled 887 patients from nine eligible studies. Pooled estimates of sensitivity and specificity were 93% (95% CI, 0.91-0.95) and 80% (95% CI, 0.75-0.85), respectively. Subgroup analyses were carried out on the main results after excluding two outliers. Area under summary receiver operating characteristics curve was 0.97. No publication bias was found using funnel plots. No significant relationship was found between the diagnostic odds ratios and the characteristics of the studies including continent and contrast agent.

Conclusions: This meta-analysis showed that CH-EUS with qualitative analysis of enhancement pattern is useful for the diagnosis of PC, and has high sensitivity and accuracy, regardless of the type of contrast agent used. This modality may provide improved diagnostic accuracy for PC in clinical practice.
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http://dx.doi.org/10.1111/den.13290DOI Listing
March 2019