Effect of Anatomy of Major Duodenal Papilla on the Difficulty of Cannulation During Endoscopic Retrograde Cholangiopancreatography
- Conditions
- Endoscopic Retrograde CholangiopancreatographyPancreaticobiilary Diseases
- Interventions
- Other: MDP
- Registration Number
- NCT03550768
- Lead Sponsor
- Air Force Military Medical University, China
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 658
- age 18-80
- Patients with native papilla who underwent ERCP
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description MDP 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.
- Primary Outcome Measures
Name Time Method post-ERCP pancreatitis incidence 48 hours frequency of post-ERCP pancreatitis
- Secondary Outcome Measures
Name Time Method Total cannulation time 3 hours the time from the moment the sphincterotome touch the papilla to the guide wire advance into the target duct.
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.
Cannulation attempts 3 hours the sphincterotome touching the papilla for at least 5 seconds will be considered as one attempt.
Unintended pancreatic duct cannulation 3 hours the guide wire unintentionally entered into the undesired pancreatic duct
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.
Trial Locations
- Locations (4)
Huaihe Hospital of Henan University
🇨🇳Kaifeng, Henan, China
Department of gastroenterology, Successful Hospital of Xiamen university
🇨🇳Xiamen, Fujian, China
Endoscopic center, Xijing Hospital of Digestive Diseases
🇨🇳Xi'an, Shaanxi, China
Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, China