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

Bleeding Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03725319
• Other study ID #: PSB Epiverstent 01
• Status: Completed
• Start date: October 29, 2018
• Est. completion date: December 15, 2018

Study information

• Verified date: March 2020
• Source: Theresienkrankenhaus und St. Hedwig-Klinik GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 15, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bleeding
• Endoscopic Biliary Sphincterotomy
• Hemorrhage

Locations

Country	Name	City	State
Germany	Tertiary referral hospital: Theresienkrankenhaus und St. Hedwig Hospital, Academic	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Theresienkrankenhaus und St. Hedwig-Klinik GmbH

Country where clinical trial is conducted

Germany, 

References & 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. Epub 2007 May 17. Review. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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