Clinical Trials Directory

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.