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Completed

NCT Number: NCT01873079

PPI for Prevention of Post-sphincterotomy Bleeding

Endoscopic biliary sphincterotomy is a common and important procedure for biliary access and therapy during endoscopic retrograde cholangiopancreatography (ERCP). Bleeding is one of the important complications related to sphincterotomy. This study determines the role of proton pump inhibitor (PPI) in preventing post-sphincterotomy bleeding in patients undergoing ERCP and sphincterotomy.

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Key information

Conditions

Bleeding ERCP Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Queen Mary Hospital

Hong Kong, China

About this study

Eligible patients will be randomized to receive either high dose PPI or standard care. PPI will be given before ERCP and continue for one week after the sphincterotomy.

Both overt and occult bleeding will be documented up to 10 days after the sphincterotomy. Bleeding rates of the two groups will be compared.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Consecutive patients undergoing ERCP who will require sphincterotomy

Exclusion criteria

  • Previous sphincterotomy/papillotomy
  • Previous Polya gastrectomy
  • Patients on maintenance PPI
  • Pregnant and lactating women
  • Age <18 years
  • Previous liver transplant
  • unable to consent for study

Treatment and study plan

Esomeprazole

Drug

Other names: Nexium

Standard care

Other

No PPI or other study medication given

Primary outcomes

  1. Proportion of patients with bleeding after sphincterotomy

    Time frame: 10 days

Secondary outcomes

  1. Proportion of patients who require transfusion, endoscopic hemostasis and other intervention to control bleeding

    Time frame: 10 days

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Prevention of Delayed Post-sphincterotomy Bleeding by High Dose Proton Pump Inhibitor

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 7, 2013
Registry last updated
Jul 18, 2016

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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