Bleeding, Endoscopic Biliary Sphincterotomy
Conditions
Keywords
Endoscopic Biliary Sphincterotomy, Endoscopic Retrograde Cholangiopancreatography, Bleeding, Epinephrine, Stent
Brief 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.
Interventions
None listed
Sponsors
Theresienkrankenhaus und St. Hedwig-Klinik GmbH
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Post sphincterotomy bleeding (PSB) of the papilla (time frame: from procedure up to ten days after the procedure) * Treatment of PSB by epinephrine-injection or insertion of a plastic stent into the common bile duct
Exclusion criteria
* Pregnant and/or lactating women * Complete patient record is not available
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical success | From the successful endocopic treatment of post sphincterotomy-bleeding up to 30 days in the follow up | No re-bleeding occurs in the follow-up that requirers a further interventional treatment of re-bleeding (any endoscopic, radiological embolization or surgery): yes/no |
| Re-interventions | From the endoscopic treatment of post-sphincterotomy-bleeding up to three months | Amount of endoscopic re-interventions (further endoscopic therapy of re-bleeding of the papilla, removal or exchange of the plastic stent): number (n) |
| Hospital stay after treatment | From the endoscopic treatment of post-sphincterotomy-bleeding up to 30 days | Hospital stay (days) after treatment of post sphincterotomy-bleeding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post ERCP-pancreatitis | From the endoscopic treatment of post-sphincterotomy-bleeding up to three days | Any kind of post ERCP-pancreatitis that occurs after treatment of post sphincterotomy-bleeding and can be refered to this treatment (patients with cannulated pancreatic duct are excluded): yes/no |
| Increasing of cholestasis parameters | From treatment of post-sphincterotomy-bleeding up to three days | Any kind of cholestasis measured by an increase of bilirubin level (mg/dl) after the treatment of post-sphincterotomy-bleeding that can be refered to this treatment (patients with unsuccesful endoscopic drainage/stone extraction are excluded): yes/no |
Countries
Germany
Outcome results
None listed