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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

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.

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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.

Conditions

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Endoscopy Peptic Ulcer Bleeding Proton Pump Inhibitors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

High dose pantoprazole infusion

Group Type EXPERIMENTAL

High dose pantoprazole infusion

Intervention Type DRUG

Pantoprazole 80mg iv bolus, 8mg/hr infusion for 72hrs

2

standard dose pantoprazole infusion

Group Type ACTIVE_COMPARATOR

Standard dose pantoprazole infusion

Intervention Type DRUG

Pantoprazole 40mg iv bolus qd x 3 days

Interventions

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High dose pantoprazole infusion

Pantoprazole 80mg iv bolus, 8mg/hr infusion for 72hrs

Intervention Type DRUG

Standard dose pantoprazole infusion

Pantoprazole 40mg iv bolus qd x 3 days

Intervention Type DRUG

Other Intervention Names

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Pantoloc Pantoloc

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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No