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

Not Applicable

• Conditions: Endoscopy; Peptic Ulcer; Bleeding; Proton Pump Inhibitors
• Interventions: Drug: High dose pantoprazole infusion; Drug: Standard dose pantoprazole infusion

• Registration Number: NCT00709046
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-06-30
• Study First Submitted QC: 2008-07-02
• Study First Posted: 2008-07-03
• Status Verified: 2010-01
• Primary Completion: 2010-01
• Last Update Submitted: 2010-01-11
• Last Update Posted: 2010-01-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	High dose pantoprazole infusion	High dose pantoprazole infusion
2	Standard dose pantoprazole infusion	standard dose pantoprazole infusion

Primary Outcome Measures

Name	Time	Method
rate of initial hemostasis and the rate of recurrent bleeding	72hr

Secondary Outcome Measures

Name	Time	Method
need for surgical intervention to control bleeding, transfusion requirements, length of hospital stay (in days), and 30-day mortality	30day

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan