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

• Sponsor: Air Force Military Medical University, China (Other)
• Overall Status: Completed
• CT.gov ID: NCT03550768
• Collaborator: The Second Affiliated Hospital of Chongqing Medical University (Other), Huaihe Hospital of Henan University (Other), Successful Hospital of Xiamen university (Other)
• Enrollment: 658
• Locations: 4
• Actual Duration (Months): 11.8
• Patients Per Site: 164.5
• Patients Per Site Per Month: 14

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreaticobiilary Diseases; Endoscopic Retrograde Cholangiopancreatography	Other: MDP

Study Design

• Study Type: Observational
• Actual Enrollment: 658 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Effect of Anatomy of Major Duodenal Papilla on the Difficulty of Cannulation During Endoscopic Retrograde Cholangiopancreatography (ERCP)
• Actual Study Start Date: May 7, 2018
• Actual Primary Completion Date: Apr 20, 2019
• Actual Study Completion Date: Apr 30, 2019

Arms and Interventions

Arm

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

Outcome Measures

Primary Outcome Measures

1. post-ERCP pancreatitis incidence [48 hours]

   frequency of post-ERCP pancreatitis

Secondary Outcome Measures

1. Rate of difficult cannulation [3 hours]

   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.

2. Cannulation attempts [3 hours]

   the sphincterotome touching the papilla for at least 5 seconds will be considered as one attempt.

3. Total cannulation time [3 hours]

   the time from the moment the sphincterotome touch the papilla to the guide wire advance into the target duct.

4. Unintended pancreatic duct cannulation [3 hours]

   the guide wire unintentionally entered into the undesired pancreatic duct

5. Complication rate [48 hours]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of gastroenterology, Successful Hospital of Xiamen university	Xiamen	Fujian	China	361001
2	Huaihe Hospital of Henan University	Kaifeng	Henan	China	475000
3	Endoscopic center, Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi	China	710032
4	Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University	Chongqing		China	400010

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yanglin Pan, Associate Professor, Air Force Military Medical University, China
• ClinicalTrials.gov Identifier: NCT03550768
• Other Study ID Numbers: KY20180081-2
• First Posted: Jun 8, 2018
• Last Update Posted: Dec 26, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yanglin Pan, Associate Professor, Air Force Military Medical University, China: ERCP; anatomy of major duodenal papilla

Study Results

No Results Posted as of Dec 26, 2019