PPI for Prevention of Post-sphincterotomy Bleeding

NCT ID: NCT01873079

Last Updated: 2016-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bleeding ERCP

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Esomeprazole

esomeprazole 40mg bd for 10 days

Group Type ACTIVE_COMPARATOR

Esomeprazole

Intervention Type DRUG

Standard care

No other study drug or placebo will be given

Group Type SHAM_COMPARATOR

Standard care

Intervention Type OTHER

No PPI or other study medication given

Interventions

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Esomeprazole

Intervention Type DRUG

Standard care

No PPI or other study medication given

Intervention Type OTHER

Other Intervention Names

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Nexium

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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LEUNG Wai Keung

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wai K Leung, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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Queen Mary Hospital

Hong Kong, , China

Site Status

Countries

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China

Other Identifiers

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ERCP-PPI ver. 2

Identifier Type: -

Identifier Source: org_study_id

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