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

Air Force Military Medical University of People's Liberation Army

Status: Completed

Conditions: Endoscopic Retrograde Cholangiopancreatography; Pancreaticobiilary Diseases

Treatments: Other: MDP

Study type: Observational

Funder types: Other

Identifiers

NCT03550768

KY20180081-2

Details and patient eligibility

About

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.

Enrollment: 658 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

658 participants in 1 patient group

MDP

Description:

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.

Treatment:

Other: MDP