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The impact of proton pump inhibitor (PPI) on the prevention of post-sphincterotomy bleeding: a prospective, randomized and controlled trial

The impact of proton pump inhibitor (PPI) on the prevention of post-sphincterotomy bleeding: a prospective, randomized and controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034697
Enrollment
Unknown
Registered
2020-07-15
Start date
2020-07-20
Completion date
Unknown
Last updated
2020-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Obstruction

Interventions

Experimental Group:Esomeprazole sodium for injection 40mg + normal saline 100ml was input into the patient by intravenous drip for 30min (200ml/h), bid (2 times a day, starting at 9 am and 4 pm respec
Control Group:100ml of normal saline was input into the patient by intravenous drip for 30min (200ml/h), bid (2 times a day, starting at 9 am and 4 pm respectively) and stopped after 48 hours. No PPIs

Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Patients who agreed to sign informed consent; (2) Patients aged between 18 and 80 years old; (3) Patients who had performed EST in our hospital within 24 hours before enrollment,and had no active bleeding before enrollment.

Exclusion criteria

Exclusion criteria: (1) Severe liver dysfunction (Child-Pugh B or C grade); (2) Severe renal insufficiency with endogenous creatinine clearance rate 1.5, PT prolonged for more than 3 seconds, APTT > 1.5 times the upper limit of normal or patients or patients who are receiving low molecular weight heparin treatment; (4) Patients with gastrointestinal bleeding due to peptic ulcer or bleeding combined with the following reasons: esophageal varices, reflux esophagitis, Mallory-Weiss syndrome, Dieulafoy disease, and post-gastrectomy ulcers of the distal stomach; (5) Preoperative acute pancreatitis; (6) Patients who need anticoagulant therapy within the first 7 days of the study; (7) Patients with active cardiovascular and cerebrovascular diseases; (8) Women who are pregnant or breastfeeding; (9) Patients who are known or suspected to be allergic to any PPI; (10) Patients who participated in any study of experimental drugs within 30 days before enrollment; (11) Patients who used PPIs more than once within 24 hours before enrollment.

Design outcomes

Primary

MeasureTime frame
Bleeding rate within 48 hours and 30 days;

Secondary

MeasureTime frame
Proportion of patients requiring endoscopic treatment within 48 hours and 30 days;Proportion of patients requiring DSA intervention or surgery within 48 hours and 30 days;Transfusion volume required within 48 hours and 30 days;

Countries

China

Contacts

Public ContactLiang Zhu

Department of Gastroenterology, The First Affiliated Hospital of Nanchang University

89493075@qq.com+86 15879084023

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026