Spontaneous Dislocation and Adverse Events of a Prophylactic Pancreatic Stent: a Prospective, Randomised, Multicenter Study (SAFE PANCREAS)
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Johann Wolfgang Goethe University Hospital
- Enrollment
- 358
- Locations
- 1
- Primary Endpoint
- Number of participants with treatment-related adverse events
Overview
Brief 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.
Detailed Description
After study consent, randomization takes place into the standard group (removal of the protective pancreatic stent after 12 hours at the earliest and 10 days at the latest by esophagogastroduodenoscopy/ERCP) or into the intervention group (removal of the protective pancreatic stent after 4 weeks at the earliest, but no later than 3 months).
Both the baseline data and randomization are planned on a secure online platform (http://myresearchmanager.com).
Before removing the pancreatic stent, non-invasive diagnostics may be performed in accordance with hospital standards, and endoscopy may be omitted if the pancreatic stent is found to be displaced.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •prophylactic pancreatic stent (5Fr 4cm length)
- •informed consent
Exclusion Criteria
- •necrotising post-ercp-pancreatitis
- •pregnancy/breastfeeding
- •Billroth II
Arms & Interventions
Standard
Standard time of the removal
Intervention: standard group (Device)
Interventional - delayed removal
Stent removal after 1 - 3 months
Intervention: pancreatic stent removal (Device)
Outcomes
Primary Outcomes
Number of participants with treatment-related adverse events
Time Frame: From enrollment to the end of treatment at 6 months
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
Secondary Outcomes
- Spontaneous dislocation(From enrollment to the end of treatment 6 months)
- Follow-up examinations for pancreatic stent detection(From enrollment to the end of treatment at 6 months)
- ERCP procedures(During visit Nr 1 (Day 10 after enrollment))
- Days of hospital stay(From the date of hospital admission (Day 1) up to hospital discharge, assessed up to 90 days.)
- Explorative analysis of the collected data(Through study completion, an average of 1 year)
Investigators
Georg Dultz
Senior Physician at Clinic of Gastroenterology, Johann Wolfgang Goethe University Hospital
Johann Wolfgang Goethe University Hospital