Spontaneous Dislocation and Adverse Events of a Prophylactic Pancreatic Stent

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.

Conditions

• Stent Dislodgement
• ERCP
• Pancreas Stent
• Post-ERCP Pancreatitis
• Prophylactic Pancreatic Stent

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

Sponsors & Collaborators

• SRH Wald-Klinikum Gera GmbH

  collaborator OTHER

• Asklepios Kliniken Hamburg GmbH

  collaborator OTHER

• Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum

  collaborator UNKNOWN

• Helios Klinikum Krefeld

  collaborator UNKNOWN

• Sana Klinikum Offenbach

  collaborator OTHER

• St. Josef Hospital Bochum

  collaborator OTHER

• University Hospital, Aachen

  collaborator OTHER

• University Hospital, Essen

  collaborator OTHER

• University Hospital Freiburg

  collaborator OTHER

• Münster University Hospital, Germany

  collaborator UNKNOWN

• Medizinische Universitätsklinik Tübingen

  collaborator UNKNOWN

• University of Göttingen

  collaborator OTHER

• University Hospital, Basel, Switzerland

  collaborator OTHER

• Centrum Gastroenterologie Bethanien

  collaborator UNKNOWN

• University Hospital Munich (LMU)

  collaborator UNKNOWN

• Universitätsklinik Würzburg

  collaborator UNKNOWN

• Johann Wolfgang Goethe University Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-01

Primary Completion

2031-12-31

Completion

2032-06-30

Countries

• Germany

Study Locations