Treatment of Post Sphincterotomy-bleeding by Epinephrine-injection Versus Insertion of an Plastic Stent

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Endoscopic Biliary Sphincterotomy, Bleeding

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Epinephrin injection<br>Diluted Epinephrin (1:100) in small amounts from 1 to 5 ml is injected into apex of the papilla to stop post sphincterotomy-bleeding | |
| Plastic stent insertion<br>A plastic stent (diameter: 8-11,5F and length of 50 -100mm) is inserted into the common bile duct to stop post sphincterotomy-bleeding | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical success | 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 | From the successful endocopic treatment of post sphincterotomy-bleeding up to 30 days in the follow up | 
| Re-interventions | Amount of endoscopic re-interventions (further endoscopic therapy of re-bleeding of the papilla, removal or exchange of the plastic stent): number (n) | From the endoscopic treatment of post-sphincterotomy-bleeding up to three months | 
| Hospital stay after treatment | Hospital stay (days) after treatment of post sphincterotomy-bleeding | From the endoscopic treatment of post-sphincterotomy-bleeding up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post ERCP-pancreatitis | 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 | From the endoscopic treatment of post-sphincterotomy-bleeding up to three days | 
| Increasing of cholestasis parameters | 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 | From treatment of post-sphincterotomy-bleeding up to three days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic Biliary Sphincterotomy, Endoscopic Retrograde Cholangiopancreatography, Bleeding, Epinephrine, Stent