High Dose Versus Standard Dose Proton Pump Inhibitor (PPI) in High-risk Bleeding Peptic Ulcers After Combined Endoscopic Treatment

Study Overview
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Brief Summary
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The study was designed to evaluate the efficacy an adjuvant use of standard dose or high dose of proton pump inhibitor after combined endoscopic hemostasis therapy.

Detailed Description
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Acute peptic ulcer bleeding remains the most common cause of acute upper gastrointestinal bleeding. Endoscopy serves as a tool for initial diagnosis and triage and also a tool for immediate hemostasis, especially for high-risk lesions. High-risk lesions include peptic ulcers with active spurting vessel, oozing vessel, or NBVV, nonbleeding visible vessel. Current modalities of endoscopic hemostasis include epinephrine injection, endoscopic coaptive thermocoagulation, hemoclipping. Endoscopic hemostasis has been documented by a number of clinical studies to be effective in decreasing rebleeding, need for emergency surgery, decreasing hospitalization days. Current evidence also shows that combination therapy with epinephrine injection and heater probe thermocoagulation/hemo-clip hemostasis is more effective than epinephrine injection alone or than heater probe thermocoagulation alone, or than hemoclip hemostasis alone. Studies showed a high dose intravenous proton pump inhibitor infusion after initial endoscopic hemostasis reduced recurrent ulcer bleeding. However, it was still controversial whether an adjuvant use of standard-dose proton pump inhibitor therapy to endoscopic therapy had similar benefit. We hypothesized that an adjuvant use of standard dose of proton pump inhibitor after combined endoscopic hemostasis therapy offer similar benefit as high dose proton pump inhibitor did.

Official Title
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High Dose Versus Standard Dose Proton Pump Inhibitor in High-risk Bleeding Peptic Ulcers After Combined Endoscopic Hemostasis: A Prospective Randomized Comparative Study

Conditions
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Endoscopy, Peptic Ulcer, Bleeding, Proton Pump Inhibitors

Intervention / Treatment
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* Drug: High dose pantoprazole infusion
* Drug: Standard dose pantoprazole infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults aged above 16 years old with acute nonvariceal upper gastrointestinal bleeding read, agree to attend the study, and signed informed consent indicated to receive esophagogastroduodenoscopy(EGD) peptic ulcers with high risk lesions (active bleeding: spurting, oozing peptic ulcers. Ulcers with NBVV: nonbleeding visible vessel) Exclusion Criteria: unable to receive EGD (unable to open mouth, upper gastrointestinal obstruction) bleeding tendency (platelet < 50x109/L, prothrombin time INR >2, ongoing use of heparin or coumadin) gastric malignancy myocardial infarction within recent one week recent cerebrovascular event within recent one week pregnancy refuse to attend the study known allergy history to epinephrine or pantoprazole

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>High dose pantoprazole infusion | Drug: High dose pantoprazole infusion<br>* Pantoprazole 80mg iv bolus, 8mg/hr infusion for 72hrs<br>* Other names: Pantoloc;|
| Active Comparator: 2<br>standard dose pantoprazole infusion | Drug: Standard dose pantoprazole infusion<br>* Pantoprazole 40mg iv bolus qd x 3 days<br>* Other names: Pantoloc;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of initial hemostasis and the rate of recurrent bleeding |  | 72hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| need for surgical intervention to control bleeding, transfusion requirements, length of hospital stay (in days), and 30-day mortality |  | 30day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic treatment, Peptic ulcer, Bleeding, Thermocoagulation, Proton pump inhibitors