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

National Taiwan University

Status: Unknown

Conditions: Peptic Ulcer; Endoscopy; Proton Pump Inhibitors; Bleeding

Treatments: Drug: High dose pantoprazole infusion; Drug: Standard dose pantoprazole infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT00709046

200710033M

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

1

Experimental group

Description:

High dose pantoprazole infusion

Treatment:

Drug: High dose pantoprazole infusion

2

Active Comparator group

Description:

standard dose pantoprazole infusion

Treatment:

Drug: Standard dose pantoprazole infusion