PPI for Prevention of Post-sphincterotomy Bleeding | NCT01873079

Studies
PPI for Prevention of Post-sphincterotomy Bleeding

NCT01873079

Sponsor

The University of Hong Kong

Status

Completed

Last Update Posted

Jul 18, 2016Estimated

Enrollment

185Actual

Phase

Phase 3

Conditions

Bleeding
ERCP

Interventions

Esomeprazole
Standard care

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Mar 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Jun 5, 2013

First Submission Date that Met QC Criteria

Jun 5, 2013

First Posted Date

Jun 7, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2016

Last Update Posted Date

Jul 18, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

185Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Esomeprazole	Drug		Esomeprazole	Nexium
Standard care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of patients with bleeding after sphincterotomy		10 days

Secondary Outcomes

Measure	Description	Time Frame
Proportion of patients who require transfusion, endoscopic hemostasis and other intervention to control bleeding		10 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wai K Leung, MD	The University of Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Queen Mary Hospital		Hong Kong			China

Condition Browse Module

MeSH Terms

ID	Term
D006470	Hemorrhage

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D064098	Esomeprazole
D059039	Standard of Care

Ancestor Terms

ID	Term
D009853	Omeprazole
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds

Browse Leaves

Not provided

Browse Branches

Not provided