Treatment of Post Sphincterotomy-bleeding by Epinephrine-injection Versus Insertion of an Plastic Stent
NCT ID: NCT03725319
Last Updated: 2020-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2018-10-29
2018-12-15
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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
No interventions assigned to this group
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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Treatment of PSB by epinephrine-injection or insertion of a plastic stent into the common bile duct
Exclusion Criteria
* Complete patient record is not available
18 Years
ALL
No
Sponsors
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Theresienkrankenhaus und St. Hedwig-Klinik GmbH
OTHER
Responsible Party
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Daniel Schmitz
Assistant medical director
Principal Investigators
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Daniel Schmitz, Dr.med.
Role: PRINCIPAL_INVESTIGATOR
Theresienkrankenhaus und St.Hedwigsklinik GmbH, Bassermannstr.1, 68165 Mannheim
Locations
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Tertiary referral hospital: Theresienkrankenhaus und St. Hedwig Hospital, Academic
Mannheim, , Germany
Countries
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References
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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. doi: 10.1111/j.1572-0241.2007.01279.x. Epub 2007 May 17.
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. doi: 10.1056/NEJM199609263351301.
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. doi: 10.1016/s0016-5107(91)70740-2.
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. doi: 10.1016/s0016-5107(00)70425-1. No abstract available.
Other Identifiers
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PSB Epiverstent 01
Identifier Type: -
Identifier Source: org_study_id
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