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

Study Overview
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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.

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

Conditions
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Pancreaticobiilary Diseases, Endoscopic Retrograde Cholangiopancreatography

Intervention / Treatment
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* Other: MDP


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MDP<br>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<br>* evaluate the anatomy of each major duodenal papilla before selective cannulation during ERCP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-ERCP pancreatitis incidence | frequency of post-ERCP pancreatitis | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of difficult cannulation | 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. | 3 hours | 
| Cannulation attempts | the sphincterotome touching the papilla for at least 5 seconds will be considered as one attempt. | 3 hours | 
| Total cannulation time | the time from the moment the sphincterotome touch the papilla to the guide wire advance into the target duct. | 3 hours | 
| Unintended pancreatic duct cannulation | the guide wire unintentionally entered into the undesired pancreatic duct | 3 hours | 
| Complication rate | 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. | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERCP, anatomy of major duodenal papilla