PPI for Prevention of Post-sphincterotomy Bleeding

The University of Hong Kong (HKU)

Status and phase: Completed; Phase 3

Conditions: ERCP; Bleeding

Treatments: Drug: Esomeprazole; Other: Standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT01873079

ERCP-PPI ver. 2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 185 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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185 participants in 2 patient groups

Esomeprazole

Active Comparator group

Description:

esomeprazole 40mg bd for 10 days

Treatment:

Drug: Esomeprazole

Standard care

Sham Comparator group

Description:

No other study drug or placebo will be given

Treatment:

Other: Standard care