Effectiveness of prophylaxis of post-ERCP pancreatitis for risk group by an endoscopic pancreatic spontaneous dislodgement stent -randomized controlled multicenter trial

Phase 3

• Conditions: Effectiveness of prophylaxis of post-ERCP pancreatitis for risk group by an endoscopic pancreatic spontaneous dislodgement stent -randomized controlled multicenter trial-

• Registration Number: JPRN-UMIN000004324
• Lead Sponsor: Japan Pancreatic Stent-Study Group (JPS-SG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2008-06-01
• Study Start: 2010-10-04
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

The following cases were excluded: 1) cases who could not provide written informed consent, 2) cases deemed inappropriate for this trial (although there were none in the present study), 3) cases with a performance status of 4, 4) cases in which the duodenal papilla could not be accessed endoscopically, 5) cases requiring pancreatic duct drainage, 6) cases with a history of prior ERCP procedures, 7) cases of postgastrectomy, 8) cases requiring endoscopic papillectomy, 9) cases of pancreatic head cancer with main pancreatic duct occlusion, 10) cases of pancreas divisum (excluding such cases at the stage when diagnosed by ERCP, due to the difficulty of diagnosis before pre-ERCP), 11) cases of chronic pancreatitis, 12) cases of intraductal papillary mucinous neoplasms (IPMN), 13) cases of gallstone pancreatitis, 14) cases of pancreaticobiliary maljunction, and 15) cases in which the ERCP procedure was not completed within 1 hour from the transoral insertion of the scope.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary study endpoints were the frequency and severity of post-ERCP pancreatitis in patients with risk factors. We also evaluated hyperamylasemia, the success rate of stent placement, the duration before stent dislodgment, and complications in both groups. We also evaluated risk factors for post-ERCP pancreatitis.