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

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

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.

Study Overview

• Status: Completed
• Conditions: Endoscopic Retrograde Cholangiopancreatography; Pancreaticobiilary Diseases
• Intervention / Treatment: Other: MDP

• Study Type: Observational
• Enrollment (Actual): 658

Contacts and Locations

Study Locations

• China
  • Chongqing, China, 400010
    • Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University
  • Fujian
    • Xiamen, Fujian, China, 361001
      • Department of gastroenterology, Successful Hospital of Xiamen university
  • Henan
    • Kaifeng, Henan, China, 475000
      • Huaihe Hospital of Henan University
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Endoscopic center, Xijing Hospital of Digestive Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with native papilla who underwent ERCP

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post-ERCP pancreatitis incidence	frequency of post-ERCP pancreatitis	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of difficult cannulation	difficult cannulation was defined as when total cannulation time was more than 5minutes, total cannulation attempts more than 5 times or inadvertent pancreatic duct cannulation more than 1 time.	3 hours
Cannulation attempts	the sphincterotome touching the papilla for at least 5 seconds will be considered as one attempt.	3 hours
Total cannulation time	the time from the moment the sphincterotome touch the papilla to the guide wire advance into the target duct.	3 hours
Unintended pancreatic duct cannulation	the guide wire unintentionally entered into the undesired pancreatic duct	3 hours
Complication rate	frequency of any adverse outcome that required hospital admission or prolonged hospital stay necessary for management of the complication, including pancreatitis, bleeding, biliary infection or perforation.	48 hours

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2018
• Primary Completion (Actual): April 20, 2019
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: May 16, 2018
• First Submitted That Met QC Criteria: June 7, 2018
• First Posted (Actual): June 8, 2018

Study Record Updates

• Last Update Posted (Actual): December 26, 2019
• Last Update Submitted That Met QC Criteria: December 24, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: ERCP; anatomy of major duodenal papilla
• Other Study ID Numbers: KY20180081-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No