An interventional study of pancreatic stent removal and standard group in Stent Dislodgement, ERCP and Pancreas Stent, sponsored by Johann Wolfgang Goethe University Hospital. Not yet recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-16.
Sponsored by Johann Wolfgang Goethe University Hospital · Not applicable, Interventional, and Treatment
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.
557 studies on the registry are indexed under Pancreatitis; 164 are open to participants now.
This study's planned enrollment of 358 is above the median of 100 across 349 interventional studies indexed under Pancreatitis.
Browse Pancreatitis studies →Johann Wolfgang Goethe University Hospital is the lead sponsor of 160 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard time of the removal
Device: standard group
Stent removal after 1 - 3 months
Device: pancreatic stent removal
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
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
Plan to share: No
Start is estimated for Jan 2026; primary completion for Dec 2031, 71 months later.
Of 91 non-industry interventional studies with no phase under Pancreatitis, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 59. This study's planned 71 months is above that.
Counting every sponsor, half of 94 studies reached it within 32 months; a quarter within 23 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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