Effect of Anatomy of Major Duodenal Papilla on the Difficulty of Cannulation During Endoscopic Retrograde Cholangiopancreatography

NCT03550768 | Completed DMC

• 1 other identifier: KY20180081-2
• Study Type: observational
• Target: 658
• Locations: 1 country
• Sites: 4

Brief Summary

Selective cannulation is an essential step for the success of ERCP. The successful cannulation is influenced by types of disease (such as Sphincter of Oddi Dysfunction and duodenal stricture), the experience of endoscopists and the anatomy of papilla. It is suggested that the size, morphology, orientation and location of major duodenal papilla (MDP), could cause a difficult cannulation (Endoscopy 2016; 48: 657-683). However, the related evidences are limited. The investigators hypothesized that special anatomy of papilla, such as a lanky shape (defined by the higher ratio of length to width) and a deeper location, could increase the difficulty of cannulation. Here the investigators investigated the effects of the anatomy of major duodenal papilla on post-ERCP pancreatitis and the procedure of cannulation in patients undergoing ERCP.

Conditions

Pancreaticobiilary Diseases; Endoscopic Retrograde Cholangiopancreatography

Keywords

ERCP; anatomy of major duodenal papilla

Outcome Measures

Primary Outcomes (1)

• post-ERCP pancreatitis incidence

  frequency of post-ERCP pancreatitis

  48 hours

Secondary Outcomes (5)

• Rate of difficult cannulation

  3 hours

• Cannulation attempts

  3 hours

• Total cannulation time

  3 hours

• Unintended pancreatic duct cannulation

  3 hours

• Complication rate

  48 hours

Study Arms (1)

MDP

ERCP was performed by trainees or trainers. Before the cannulation, the photo of major duodenal papilla will be taken carefully to evaluate its size, morphology, orientation and location. All patients initially received wire-guided cannulation with a sphincterotome, If cannulation failed, precut sphincterotomy or the double-wire technique was performed when appropriate. Therapeutic manipulation (eg, sphincterotomy, balloon dilation, stone extraction, and stenting) was done when appropriate. Pancreatic duct stent placement was performed at the discretion of the endoscopists.

Other: MDP

Interventions

MDP OTHER

evaluate the anatomy of each major duodenal papilla before selective cannulation during ERCP

MDP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with native papilla who underwent ERCP

You may qualify if:

• age 18-80
• Patients with native papilla who underwent ERCP

You may not qualify if:

• Prior endoscopic sphincterotomy
• Minor pancreatic duct as the targeted duct
• History of prior upper gastrointestinal surgery, such as Billroth I, II and Roux-en-Y
• Fistula of MDP
• Papillary carcinoma or adenoma
• Duodenal obstruction, type II
• Prior stent placement in common bile duct or pancreatic duct
• Pregnant or breastfeeding women
• Unwilling or inability to provide consent

Sponsors & Collaborators

• Air Force Military Medical University, China: lead
• The Second Affiliated Hospital of Chongqing Medical University: collaborator
• Huaihe Hospital of Henan University: collaborator
• Successful Hospital of Xiamen university: collaborator

Study Sites (4)

Department of gastroenterology, Successful Hospital of Xiamen university

Xiamen, Fujian, 361001, China

Location

Huaihe Hospital of Henan University

Kaifeng, Henan, 475000, China

Location

Endoscopic center, Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

Location

Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University

Chongqing, 400010, China

Location

Related Publications (1)

• Wang X, Zhao J, Wang L, Ning B, Zeng W, Tao Q, Ren G, Liang S, Luo H, Wang B, Farrell JJ, Pan Y, Guo X, Wu K. Relationship between papilla-related variables and post endoscopic retrograde cholangiopancreatography pancreatitis: A multicenter, prospective study. J Gastroenterol Hepatol. 2020 Dec;35(12):2184-2191. doi: 10.1111/jgh.15135. Epub 2020 Jun 29.

  PMID: 32511794 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: June 8, 2018
• Study Start: May 7, 2018
• Primary Completion: April 20, 2019
• Study Completion: April 30, 2019
• Last Updated: December 26, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)