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

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ClinicalTrials.gov Identifier: NCT03550768
Recruitment Status : Completed
First Posted : June 8, 2018
Last Update Posted : July 4, 2019
Sponsor:
Collaborators:
The Second Affiliated Hospital of Chongqing Medical University
Huaihe Hospital of Henan University
Chinese PLA 174 Hospital
Information provided by (Responsible Party):
Yanglin Pan, Fourth Military Medical University

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 the difficulty of cannulation in patients undergoing ERCP.

Condition or disease Intervention/treatment
Pancreaticobiilary Diseases Endoscopic Retrograde Cholangiopancreatography Other: MDP

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Study Type : Observational
Actual Enrollment : 600 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 : April 20, 2019
Actual Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anatomy Endoscopy

Group/Cohort 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




Primary Outcome Measures :
  1. post-ERCP pancreatitis incidence [ Time Frame: 48 hours ]
    frequency of post-ERCP pancreatitis


Secondary Outcome Measures :
  1. Cannulation attempts [ Time Frame: 3 hours ]
    the sphincterotome touching the papilla for at least 5 seconds will be considered as one attempt.

  2. Total cannulation time [ Time Frame: 3 hours ]
    the time from the moment the sphincterotome touch the papilla to the guide wire advance into the target duct.

  3. Unintended pancreatic duct cannulation [ Time Frame: 3 hours ]
    the guide wire unintentionally enter into the undesired pancreatic duct

  4. Complication rate [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with native papilla who underwent ERCP
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03550768


Locations
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China, Fujian
Department of gastroenterology, Chinese PLA 174 Hospital
Xiamen, Fujian, China, 361001
China, Henan
Huaihe Hospital of Henan University
Kaifeng, Henan, China, 475000
China, Shaanxi
Endoscopic center, Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China, 710032
China
Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University
Chongqing, China, 400010
Sponsors and Collaborators
Fourth Military Medical University
The Second Affiliated Hospital of Chongqing Medical University
Huaihe Hospital of Henan University
Chinese PLA 174 Hospital

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Responsible Party: Yanglin Pan, associate Professor, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT03550768     History of Changes
Other Study ID Numbers: KY20180081-2
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yanglin Pan, Fourth Military Medical University:
ERCP
anatomy of major duodenal papilla