Treatment of Post Sphincterotomy-bleeding by Epinephrine-injection Versus Insertion of an Plastic Stent
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Epinephrin injection 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 A plastic stent (diameter: 8-11,5F and length of 50 -100mm) is inserted into the common bile duct to stop post sphincterotomy-bleeding |
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Post sphincterotomy bleeding (PSB) of the papilla (time frame: from procedure up to ten days after the procedure)
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Treatment of PSB by epinephrine-injection or insertion of a plastic stent into the common bile duct
Exclusion Criteria:
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Pregnant and/or lactating women
-
Complete patient record is not available
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tertiary referral hospital: Theresienkrankenhaus und St. Hedwig Hospital, Academic | Mannheim | Germany | 68165 |
Sponsors and Collaborators
- Theresienkrankenhaus und St. Hedwig-Klinik GmbH
Investigators
- Principal Investigator: Daniel Schmitz, Dr.med., Theresienkrankenhaus und St.Hedwigsklinik GmbH, Bassermannstr.1, 68165 Mannheim
Study Documents (Full-Text)
None provided.More Information
Publications
- Andriulli A, Loperfido S, Napolitano G, Niro G, Valvano MR, Spirito F, Pilotto A, Forlano R. Incidence rates of post-ERCP complications: a systematic survey of prospective studies. Am J Gastroenterol. 2007 Aug;102(8):1781-8. Epub 2007 May 17. Review.
- Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991 May-Jun;37(3):383-93. Review.
- Freeman ML, Nelson DB, Sherman S, Haber GB, Herman ME, Dorsher PJ, Moore JP, Fennerty MB, Ryan ME, Shaw MJ, Lande JD, Pheley AM. Complications of endoscopic biliary sphincterotomy. N Engl J Med. 1996 Sep 26;335(13):909-18.
- Matsushita M, Hajiro K, Takakuwa H, Nishio A. Effective hemostatic injection above the bleeding site for uncontrolled bleeding after endoscopic sphincterotomy. Gastrointest Endosc. 2000 Feb;51(2):221-3.
- PSB Epiverstent 01