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| Name | Class |
|---|---|
| SRH Wald-Klinikum Gera GmbH | OTHER |
| Asklepios Kliniken Hamburg GmbH | OTHER |
| Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard | Active Comparator | Standard time of the removal |
|
| Interventional - delayed removal | Experimental | Stent removal after 1 - 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pancreatic stent removal | Device | Removal of the pancreatic stent after 1 - 3 months after the placement |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to the end of treatment at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to the end of treatment 6 months |
| Follow-up examinations for pancreatic stent detection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Florian Michael, Dr. med. | Contact | 004915117191302 | Fmichael@med.uni-frankfurt.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johann Wolfgang Goethe-Universität Frankfurt am Main | Frankfurt | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39222928 | Result | Michael FA, Feldmann C, Erasmus HP, Kubesch A, Goerguelue E, Knabe M, Abedin N, Heilani M, Hessz D, Graf C, Walter D, Finkelmeier F, Mihm U, Lingwal N, Zeuzem S, Bojunga J, Friedrich-Rust M, Dultz G. A novel ultrasound-based algorithm for the detection of pancreatic stents placed for prophylaxis of post-ERCP pancreatitis: a prospective trial. Ultraschall Med. 2025 Apr;46(2):177-185. doi: 10.1055/a-2407-9651. Epub 2024 Sep 2. | |
| 30502123 |
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| Helios Klinikum Krefeld |
| UNKNOWN |
| Sana Klinikum Offenbach | OTHER |
| St. Josef Hospital Bochum | OTHER |
| University Hospital, Aachen | OTHER |
| University Hospital, Essen | OTHER |
| University Hospital Freiburg | OTHER |
| Münster University Hospital, Germany | UNKNOWN |
| Medizinische Universitätsklinik Tübingen | UNKNOWN |
| University of Göttingen | OTHER |
| University Hospital, Basel, Switzerland | OTHER |
| Centrum Gastroenterologie Bethanien | UNKNOWN |
| University Hospital Munich | OTHER |
| University of Wuerzburg | OTHER |
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| standard group | Device | Removal at intervals of 12 hours up to a maximum of 10 days after the index ERCP |
|
Follow-up examinations for pancreatic stent detection - retention or spontaneous dislocation - by ultrasound, x-ray or endoscopy examination |
| 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)
| 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. | 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 | Through study completion, an average of 1 year |
| Result |
| Dultz G, Gerber L, Zeuzem S, Bojunga J, Friedrich-Rust M. Prolonged retention of prophylactic pancreatic stents is not associated with increased complications. Pancreatology. 2019 Jan;19(1):39-43. doi: 10.1016/j.pan.2018.11.011. Epub 2018 Nov 22. |
| 31863440 | Result | Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20. |