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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
358
Removal of the pancreatic stent after 1 - 3 months after the placement
Removal at intervals of 12 hours up to a maximum of 10 days after the index ERCP
Johann Wolfgang Goethe-Universität Frankfurt am Main
Frankfurt, Germany
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 months
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 months
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 months
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)
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.
Explorative analysis of the collected data
The all data collected will be evaluated and explored for factors influencing our primary endpoint
Time frame: Through study completion, an average of 1 year
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