Clinical trial NCT03725319: Treatment of Post Sphincterotomy-bleeding by Epinephrine-injection Versus Insertion of an Plastic Stent
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endoscopic Biliary Sphincterotomy
Bleeding
Keywords: Endoscopic Biliary Sphincterotomy
Endoscopic Retrograde Cholangiopancreatography
Bleeding
Epinephrine
Stent
Lead sponsor: Theresienkrankenhaus und St. Hedwig-Klinik GmbH
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All documented ERCPs in the single centre institution database are systematically screened for post sphincterotomy-bleeding in the time period from 1.1.2002 to 29.10.2018

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical success
timeFrame: From the successful endocopic treatment of post sphincterotomy-bleeding up to 30 days in the follow up
measure: Re-interventions
timeFrame: From the endoscopic treatment of post-sphincterotomy-bleeding up to three months
measure: Hospital stay after treatment
timeFrame: From the endoscopic treatment of post-sphincterotomy-bleeding up to 30 days
Secondary outcomes:
measure: Post ERCP-pancreatitis
timeFrame: From the endoscopic treatment of post-sphincterotomy-bleeding up to three days
measure: Increasing of cholestasis parameters
timeFrame: From treatment of post-sphincterotomy-bleeding up to three days
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Tertiary referral hospital: Theresienkrankenhaus und St. Hedwig Hospital, Academic
Study officials:
affiliation: Theresienkrankenhaus und St.Hedwigsklinik GmbH, Bassermannstr.1, 68165 Mannheim
name: Daniel Schmitz, Dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.