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
This trial does not accept healthy volunteersQualifiers
prophylactic pancreatic stent (5Fr 4cm length)
informed consent
Disqualifiers
necrotising post-ercp-pancreatitis
pregnancy/breastfeeding
Billroth II
Trial design
Design model
Parallel
Treatments tested in this trial
pancreatic stent removal
DeviceRemoval of the pancreatic stent after 1 - 3 months after the placement
standard group
DeviceRemoval at intervals of 12 hours up to a maximum of 10 days after the index ERCP
Treatment groups
358 Participants
are divided into 2 treatment groupsGroup A: StandardActive comparator 1 intervention
Group B: Interventional - delayed removalExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with treatment-related adverse events
Side effects (number and type) which occur due to the stent insertion, retention after more than 10 days and/or after the removal of the stent
Time frame
From enrollment to the end of treatment at 6 monthsSecondary outcomes
1
Spontaneous dislocation
Due the examinations by ultrasound and x-ray or endoscopy, the rate of how many patients had a spontaneous dislocation will be evaluated
Time frame
From enrollment to the end of treatment 6 months2
Follow-up examinations for pancreatic stent detection
Follow-up examinations for pancreatic stent detection - retention or spontaneous dislocation - by ultrasound, x-ray or endoscopy examination
Time frame
From enrollment to the end of treatment at 6 months3
ERCP procedures
Influence of measures taken during ERCP on the probability of spontaneous stent dislocation as well of patients characteristics (pancreaticobiliary disease) * questions about procedures made during the ERCP (papillotomy, stent insertion, using metallic stent, balloon dilatation) * questions about patients characteristics (chronic pancreatitis, pancreatic tumor, cholangiocarcinoma, stone extraction)
Time frame
During visit Nr 1 (Day 10 after enrollment)4
Days of hospital stay
The total number of days participants remain hospitalized from the date of admission until the date of discharge.
Time frame
From the date of hospital admission (Day 1) up to hospital discharge, assessed up to 90 days.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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
This trial is not recruiting at the moment. You can still explore other options: