Stent Dislodgement, ERCP, Pancreas Stent, Post-ERCP Pancreatitis, Prophylactic Pancreatic Stent
Conditions
Keywords
ercp, prophylactic pancreatic stent, post-ercp-pancreatitis, pancreatic stent, post-ercp pancreatitis, PEP
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.
Interventions
DEVICEpancreatic stent removal
Removal of the pancreatic stent after 1 - 3 months after the placement
DEVICEstandard group
Removal at intervals of 12 hours up to a maximum of 10 days after the index ERCP
Sponsors
Johann Wolfgang Goethe University Hospital
SRH Wald-Klinikum Gera GmbH
Asklepios Kliniken Hamburg GmbH
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
Helios Klinikum Krefeld
Sana Klinikum Offenbach
St. Josef Hospital Bochum
University Hospital, Aachen
University Hospital, Essen
University Hospital Freiburg
Münster University Hospital, Germany
Medizinische Universitätsklinik Tübingen
University of Göttingen
University Hospital, Basel, Switzerland
Centrum Gastroenterologie Bethanien
University Hospital Munich (LMU)
Universitätsklinik Würzburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* prophylactic pancreatic stent (5Fr 4cm length) * informed consent
Exclusion criteria
* necrotising post-ercp-pancreatitis * pregnancy/breastfeeding * Billroth II
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events | 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
| Measure | Time frame | Description |
|---|---|---|
| Explorative analysis of the collected data | Through study completion, an average of 1 year | The all data collected will be evaluated and explored for factors influencing our primary endpoint |
| Spontaneous dislocation | From enrollment to the end of treatment 6 months | Due the examinations by ultrasound and x-ray or endoscopy, the rate of how many patients had a spontaneous dislocation will be evaluated |
| Follow-up examinations for pancreatic stent detection | From enrollment to the end of treatment at 6 months | Follow-up examinations for pancreatic stent detection - retention or spontaneous dislocation - by ultrasound, x-ray or endoscopy examination |
| ERCP procedures | During visit Nr 1 (Day 10 after enrollment) | 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) |
| Days of hospital stay | From the date of hospital admission (Day 1) up to hospital discharge, assessed up to 90 days. | The total number of days participants remain hospitalized from the date of admission until the date of discharge. |
Countries
Germany
Contacts
CONTACTFlorian Michael, Dr. med.
Outcome results
None listed