Clinical Trial

Spontaneous Dislocation and Adverse Events of a Prophylactic Pancreatic Stent

Study acronym: SAFE PANCREAS
Not Yet Recruiting
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Summary
A multicenter, prospective, controlled randomized study to investigate the optimal duration of protective pancreatic stents after endoscopic retrograde cholangiopancreatography (ERCP). The primary endpoint is the complication rate that can be clinically attributed to the remaining pancreatic prosthesis or its removal in the study groups. Secondary endpoints are spontaneous removal of the pancreatic stent, length of hospital stay, rate of follow-up examinations per group, influencing factors, and a possible exploratory analysis.
Trial Details
NCT Number NCT07346365
Lead Sponsor Johann Wolfgang Goethe University Hospital
Collaborators: SRH Wald-Klinikum Gera GmbH, Asklepios Kliniken Hamburg GmbH, Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Helios Klinikum Krefeld, Sana Klinikum Offenbach, St. Josef Hospital Bochum, University Hospital, Aachen, University Hospital, Essen, University Hospital Freiburg, Münster University Hospital, Germany, Medizinische Universitätsklinik Tübingen, University of Göttingen, University Hospital, Basel, Switzerland, Centrum Gastroenterologie Bethanien, University Hospital Munich, University of Wuerzburg
Conditions Stent Dislodgement, ERCP, Pancreas Stent, Post-ERCP Pancreatitis, Prophylactic Pancreatic Stent
Enrollment 358 participants
Start Date 2026-01-01
Primary Completion 2031-12 (estimated)
Study Completion 2032-06 (estimated)
Updated on ClinicalTrials.gov 2026-01-16