Spontaneous Dislocation and Adverse Events of a Prophylactic Pancreatic Stent
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohann Wolfgang Goethe University Hospital
About this trial
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.
Eligibility criteria
Qualifiers
prophylactic pancreatic stent (5Fr 4cm length)
informed consent
Disqualifiers
necrotising post-ercp-pancreatitis
pregnancy/breastfeeding
Billroth II
Trial design
Treatments tested in this trial
- pancreatic stent removal
- standard group
Treatment groups
358 Participants
are divided into 2 treatment groupsSponsors and collaborators
Johann Wolfgang Goethe University Hospital
Lead sponsor
SRH Wald-Klinikum Gera GmbH
Collaborator
Asklepios Kliniken Hamburg GmbH
Collaborator
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
Collaborator
Helios Klinikum Krefeld
Collaborator
Sana Klinikum Offenbach
Collaborator
St. Josef Hospital Bochum
Collaborator
University Hospital, Aachen
Collaborator
University Hospital, Essen
Collaborator
University Hospital Freiburg
Collaborator
Münster University Hospital, Germany
Collaborator
Medizinische Universitätsklinik Tübingen
Collaborator
University of Göttingen
Collaborator
University Hospital, Basel, Switzerland
Collaborator
Centrum Gastroenterologie Bethanien
Collaborator
University Hospital Munich
Collaborator
University of Wuerzburg
Collaborator
Source ClinicalTrials.gov