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Completed

NCT Number: NCT03550768

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

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.

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Key information

Conditions

Pancreaticobiilary Diseases Endoscopic Retrograde Cholangiopancreatography

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of gastroenterology, Successful Hospital of Xiamen university, Xiamen, Fujian, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MDP

Other

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

Primary outcomes

  1. post-ERCP pancreatitis incidence

    Time frame: 48 hours

    frequency of post-ERCP pancreatitis

Secondary outcomes

  1. Rate of difficult cannulation

    Time frame: 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

    Time frame: 3 hours

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

  3. 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.

  4. Unintended pancreatic duct cannulation

    Time frame: 3 hours

    the guide wire unintentionally entered into the undesired pancreatic duct

  5. 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.

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Collaborators

  • Huaihe Hospital of Henan University
  • Successful Hospital of Xiamen university
  • The Second Affiliated Hospital of Chongqing Medical University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 8, 2018
Registry last updated
Dec 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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