Risk Factors of Post-ERCP Pancreatitis in Patients Receiving Rectal Indomethacin
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|ClinicalTrials.gov Identifier: NCT02709421|
Recruitment Status : Completed
First Posted : March 16, 2016
Last Update Posted : September 5, 2016
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||790 participants|
|Official Title:||Risk Factors Related to Post-endoscopic Retrograde Cholangiopancreatography Pancreatitis in High-risk Patients Who Underwent ERCP and Received Prophylactic Rectal Indomethacin|
|Study Start Date :||February 2016|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
All the patients with high risks of PEP received administration of one single dose of 100mg rectal indomethacin after ERCP.
Patients were considered high risk of PEP if they met one of the following criteria: clinical suspicion of sphincter of Oddi dysfunction, a history of PEP, pancreatic sphincterotomy, precut sphincterotomy, ≥8 cannulation attempts, cannulation time≥10 minutes; pneumatic dilatation of an intact biliary sphincter, ≥3 inadvertent pancreatic duct cannulation, opacification of pancreatic acini, or the acquisition of a cytologic specimen from the pancreatic duct with the use of a brush or forceps.
- Overall PEP rate [ Time Frame: 1 year ]PEP was defined if patients experienced abdominal pain for more than 24h after procedure, accompanying with amylase or lipase ≥ 3 times equal to the upper limit of normal value.
- The rate of moderate-severe pancreatitis [ Time Frame: 1 year ]
- Overall ERCP-related complication rate [ Time Frame: 1 year ]
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): NCT02709421
|Department of gastroenterology,Chinese PLA 174 Hospital|
|Xiamen, Fujian, China|
|The First Affiliated Hospital of Xi'an Jiaotong University|
|Xi'an, Shaanxi, China|
|Xijing Hospital of Digestive Diseases|
|Xi'an, Shaanxi, China|
|Principal Investigator:||Yanglin Pan||Xijing Hospital of Disgestive Diseases.The Fourth Military University|