Clinical trial NCT03550768: Effect of Anatomy of Major Duodenal Papilla on the Difficulty of Cannulation During Endoscopic Retrograde Cholangiopancreatography
Official title: Effect of Anatomy of Major Duodenal Papilla on the Difficulty of Cannulation During Endoscopic Retrograde Cholangiopancreatography (ERCP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreaticobiilary Diseases
Endoscopic Retrograde Cholangiopancreatography
Keywords: ERCP
anatomy of major duodenal papilla
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
Collaborators: name: The Second Affiliated Hospital of Chongqing Medical University
name: Huaihe Hospital of Henan University
name: Successful Hospital of Xiamen university
First posted: 2018-06-08
Enrollment: 658
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with native papilla who underwent ERCP

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.


Eligibility criteria: 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

Primary outcomes:
measure: post-ERCP pancreatitis incidence
timeFrame: 48 hours
Secondary outcomes:
measure: Rate of difficult cannulation
timeFrame: 3 hours
measure: Cannulation attempts
timeFrame: 3 hours
measure: Total cannulation time
timeFrame: 3 hours
measure: Unintended pancreatic duct cannulation
timeFrame: 3 hours
measure: Complication rate
timeFrame: 48 hours
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Department of gastroenterology, Successful Hospital of Xiamen university
state: Fujian
city: Kaifeng
country: China
facility: Huaihe Hospital of Henan University
state: Henan
city: Xi'an
country: China
facility: Endoscopic center, Xijing Hospital of Digestive Diseases
state: Shaanxi
city: Chongqing
country: China
facility: Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University
Study officials:
References:
citation: 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.