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

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

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.

Study Overview

• Status: Completed
• Conditions: Bleeding; Endoscopic Biliary Sphincterotomy

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Germany
  • Mannheim, Germany, 68165
    • Tertiary referral hospital: Theresienkrankenhaus und St. Hedwig Hospital, Academic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Theresienkrankenhaus und St. Hedwig-Klinik GmbH
• Investigators: Principal Investigator: Daniel Schmitz, Dr.med., Theresienkrankenhaus und St.Hedwigsklinik GmbH, Bassermannstr.1, 68165 Mannheim

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 29, 2018
• Primary Completion (ACTUAL): November 30, 2018
• Study Completion (ACTUAL): December 15, 2018

Study Registration Dates

• First Submitted: October 29, 2018
• First Submitted That Met QC Criteria: October 29, 2018
• First Posted (ACTUAL): October 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 19, 2020
• Last Update Submitted That Met QC Criteria: March 18, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Stent; Bleeding; Epinephrine; Endoscopic Retrograde Cholangiopancreatography; Endoscopic Biliary Sphincterotomy
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: PSB Epiverstent 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No