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

NCT03725319 | Completed

• 1 other identifier: PSB Epiverstent 01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Endoscopic Biliary Sphincterotomy; Bleeding

Keywords

Endoscopic Biliary Sphincterotomy; Endoscopic Retrograde Cholangiopancreatography; Bleeding; Epinephrine; Stent

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Post ERCP-pancreatitis

  From the endoscopic treatment of post-sphincterotomy-bleeding up to three days

• Increasing of cholestasis parameters

  From treatment of post-sphincterotomy-bleeding up to three days

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Pregnant and/or lactating women
• Complete patient record is not available

Sponsors & Collaborators

• Theresienkrankenhaus und St. Hedwig-Klinik GmbH: lead

Study Sites (1)

Tertiary referral hospital: Theresienkrankenhaus und St. Hedwig Hospital, Academic

Mannheim, 68165, Germany

Location

Related Publications (4)

• 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.

  PMID: 17509029 BACKGROUND

• 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.

  PMID: 8782497 BACKGROUND

• 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.

  PMID: 2070995 BACKGROUND

• 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.

  PMID: 10650275 BACKGROUND

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Schmitz, Dr.med.

  Theresienkrankenhaus und St.Hedwigsklinik GmbH, Bassermannstr.1, 68165 Mannheim

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant medical director

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: October 31, 2018
• Study Start: October 29, 2018
• Primary Completion: November 30, 2018
• Study Completion: December 15, 2018
• Last Updated: March 19, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)