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Completed

NCT Number: NCT03725319

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

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.

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Key information

Conditions

Endoscopic Biliary Sphincterotomy Bleeding Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Mannheim, 68165, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Clinical success

    Time frame: From the successful endocopic treatment of post sphincterotomy-bleeding up to 30 days in the follow up

    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

  2. Re-interventions

    Time frame: From the endoscopic treatment of post-sphincterotomy-bleeding up to three months

    Amount of endoscopic re-interventions (further endoscopic therapy of re-bleeding of the papilla, removal or exchange of the plastic stent): number (n)

  3. Hospital stay after treatment

    Time frame: From the endoscopic treatment of post-sphincterotomy-bleeding up to 30 days

    Hospital stay (days) after treatment of post sphincterotomy-bleeding

Secondary outcomes

  1. Post ERCP-pancreatitis

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

    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

  2. Increasing of cholestasis parameters

    Time frame: From treatment of post-sphincterotomy-bleeding up to three days

    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

Sponsors and collaborators

Lead sponsor

Theresienkrankenhaus und St. Hedwig-Klinik GmbH

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 31, 2018
Registry last updated
Mar 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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