Trials / Completed
CompletedNCT03725319
Treatment of Post Sphincterotomy-bleeding by Epinephrine-injection Versus Insertion of an Plastic Stent
Retrospective Study on Treatment of Post Sphincterotomy-bleeding by Epinephrine-injection Versus Insertion of an Endoprosthesis: a Single Center Experience Over 16 Years With 5698 ERCPs
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (actual)
- Sponsor
- Theresienkrankenhaus und St. Hedwig-Klinik GmbH · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Post sphinterotomy-bleeding (PSB) occurs in 1-2 % of Endosocpic Retrograde Cholangiopancreaticography (ERCP) and usually needs no blood transfusion after endoscopic therapy but can be life-threatening in some rare cases. There are no prospective comparative studies concerning the endoscopic treatment of PSB due to the rarity of the incident. Insertion of an endoprosthesis in the common bile duct may be more effective than Epinephrin-injection into the papilla which is the therapy of first choice. A retrospective single centre analysis on both used methods over a study period of 16 years shall be performed.
Detailed description
Post sphinterotomy-bleeding (PSB) occurs in 1-2 % of Endosocpic Retrograde Cholangiopancreaticography (ERCP) and usually needs no blood transfusion after endoscopic therapy but can be life-threatening in some rare cases. The increasing use of antiplatelet and/or anticoagulant therapies enhances the risk of PSB. There are no prospective comparative studies concerning the endoscopic treatment of PSB due to the rarity of the incident. Insertion of an endoprosthesis in the common bile duct may be more effective than Epinephrin-injection into the papilla which is the therapy of first choice. A retrospective single centre analysis on both used methods over a study period of 16 years shall be performed. In detail, clinical success and safety of the procedure, re-bleeding rate, number of re-interventions and days of hospital stay will be analysed.
Conditions
Timeline
- Start date
- 2018-10-29
- Primary completion
- 2018-11-30
- Completion
- 2018-12-15
- First posted
- 2018-10-31
- Last updated
- 2020-03-19
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03725319. Inclusion in this directory is not an endorsement.