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

Endoscopic Retrograde Cholangiopancreatography Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03550768
• Other study ID #: KY20180081-2
• Status: Completed
• Start date: May 7, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: December 2019
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 658
• Est. completion date: April 30, 2019
• Est. primary completion date: April 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Endoscopic Retrograde Cholangiopancreatography
• Pancreaticobiilary Diseases

Intervention

Other:
• MDP
evaluate the anatomy of each major duodenal papilla before selective cannulation during ERCP

Locations

Country	Name	City	State
China	Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University	Chongqing
China	Huaihe Hospital of Henan University	Kaifeng	Henan
China	Endoscopic center, Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi
China	Department of gastroenterology, Successful Hospital of Xiamen university	Xiamen	Fujian

Sponsors (4)

Lead Sponsor	Collaborator
Fourth Military Medical University	Huaihe Hospital of Henan University, Successful Hospital of Xiamen university, The Second Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post-ERCP pancreatitis incidence	frequency of post-ERCP pancreatitis	48 hours
Secondary	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
Secondary	Cannulation attempts	the sphincterotome touching the papilla for at least 5 seconds will be considered as one attempt.	3 hours
Secondary	Total cannulation time	the time from the moment the sphincterotome touch the papilla to the guide wire advance into the target duct.	3 hours
Secondary	Unintended pancreatic duct cannulation	the guide wire unintentionally entered into the undesired pancreatic duct	3 hours
Secondary	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