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

NCT ID: NCT03550768

Last Updated: 2019-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

658 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-07

Study Completion Date

2019-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreaticobiilary Diseases Endoscopic Retrograde Cholangiopancreatography

Keywords

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ERCP anatomy of major duodenal papilla

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

MDP

Intervention Type OTHER

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

Interventions

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MDP

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role collaborator

Huaihe Hospital of Henan University

OTHER

Sponsor Role collaborator

Successful Hospital of Xiamen university

UNKNOWN

Sponsor Role collaborator

Air Force Military Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Yanglin Pan

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of gastroenterology, Successful Hospital of Xiamen university

Xiamen, Fujian, China

Site Status

Huaihe Hospital of Henan University

Kaifeng, Henan, China

Site Status

Endoscopic center, Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, China

Site Status

Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University

Chongqing, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 32511794 (View on PubMed)

Other Identifiers

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KY20180081-2

Identifier Type: -

Identifier Source: org_study_id