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Clinical Trials/JPRN-UMIN000004324
JPRN-UMIN000004324
Completed
Phase 3

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

Japan Pancreatic Stent-Study Group (JPS-SG)0 sites500 target enrollmentOctober 4, 2010

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Effectiveness of prophylaxis of post-ERCP pancreatitis for risk group by an endoscopic pancreatic spontaneous dislodgement stent -randomized controlled multicenter trial-
Sponsor
Japan Pancreatic Stent-Study Group (JPS-SG)
Enrollment
500
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 4, 2010
End Date
June 1, 2008
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Japan Pancreatic Stent-Study Group (JPS-SG)

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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