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
|Condition or disease||Intervention/treatment|
|Pancreaticobiilary Diseases Endoscopic Retrograde Cholangiopancreatography||Other: MDP|
|Study Type :||Observational|
|Actual Enrollment :||600 participants|
|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|
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.
evaluate the anatomy of each major duodenal papilla before selective cannulation during ERCP
- post-ERCP pancreatitis incidence [ Time Frame: 48 hours ]frequency of post-ERCP pancreatitis
- Cannulation attempts [ Time Frame: 3 hours ]the sphincterotome touching the papilla for at least 5 seconds will be considered as one attempt.
- 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.
- Unintended pancreatic duct cannulation [ Time Frame: 3 hours ]the guide wire unintentionally enter into the undesired pancreatic duct
- 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.
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
|Department of gastroenterology, Chinese PLA 174 Hospital|
|Xiamen, Fujian, China, 361001|
|Huaihe Hospital of Henan University|
|Kaifeng, Henan, China, 475000|
|Endoscopic center, Xijing Hospital of Digestive Diseases|
|Xi'an, Shaanxi, China, 710032|
|Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University|
|Chongqing, China, 400010|