Official Title: “High Dose Versus Standard Dose Proton Pump Inhibitor in High-Risk Bleeding Peptic Ulcers After Endoscopic Epinephrine Injection and Heat Probe Thermocoagulation/Hemo-Clip Hemostasis: A Prospective Randomized Comparative Study”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Subject), Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2010

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.

Intervention(s) in this Clinical Trial

• Drug: High dose pantoprazole infusion
  • Pantoprazole 80mg iv bolus, 8mg/hr infusion for 72hrs
• Drug: Standard dose pantoprazole infusion
  • Pantoprazole 40mg iv bolus qd x 3 days

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • High dose pantoprazole infusion
• Active Comparator: 2
  • standard dose pantoprazole infusion

Primary Measures

• rate of initial hemostasis and the rate of recurrent bleeding
  • Time Frame: 72hr
    Safety Issue?: Yes

Secondary Measures

• need for surgical intervention to control bleeding, transfusion requirements, length of hospital stay (in days), and 30-day mortality
  • Time Frame: 30day
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Taiwan University Hospital

Overall Clinical Trial Officials and Contacts

Overall Contact: Chieh-Chang Chen, MD 886-5-532-3911 chiehchang.chen@gmail.com

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00709046

Study ID Number: 200710033M

ClinicalTrials.gov Identifier: NCT00709046

Health Authority: Taiwan: Department of Health