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NOT YET RECRUITING
NCT07346365
NA

Spontaneous Dislocation and Adverse Events of a Prophylactic Pancreatic Stent

Sponsor: Johann Wolfgang Goethe University Hospital

View on ClinicalTrials.gov

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.

Official title: Spontaneous Dislocation and Adverse Events of a Prophylactic Pancreatic Stent: a Prospective, Randomised, Multicenter Study (SAFE PANCREAS)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

358

Start Date

2026-01-01

Completion Date

2032-06

Last Updated

2026-01-16

Healthy Volunteers

No

Interventions

DEVICE

pancreatic stent removal

Removal of the pancreatic stent after 1 - 3 months after the placement

DEVICE

standard group

Removal at intervals of 12 hours up to a maximum of 10 days after the index ERCP

Locations (1)

Johann Wolfgang Goethe-Universität Frankfurt am Main

Frankfurt, Germany