NCT01873079

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2013

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 7, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 18, 2016

Status Verified

July 1, 2016

Enrollment Period

2.9 years

First QC Date

June 5, 2013

Last Update Submit

July 15, 2016

Conditions

BleedingERCP

Keywords

ERCPsphincterotomyproton pump inhibitor

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with bleeding after sphincterotomy

    10 days

Secondary Outcomes (1)

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

    10 days

Study Arms (2)

Esomeprazole

ACTIVE COMPARATOR

esomeprazole 40mg bd for 10 days

Drug: Esomeprazole

Standard care

SHAM COMPARATOR

No other study drug or placebo will be given

Other: Standard care

Interventions

EsomeprazoleDRUG
Also known as: Nexium
Esomeprazole
Standard careOTHER

No PPI or other study medication given

Standard care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consecutive patients undergoing ERCP who will require sphincterotomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

EsomeprazoleStandard of Care

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Wai K Leung, MD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

June 5, 2013

First Posted

June 7, 2013

Study Start

April 1, 2013

Primary Completion

March 1, 2016

Study Completion

June 1, 2016

Last Updated

July 18, 2016

Record last verified: 2016-07

Locations

CN(1)