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Sponsored by: |
National Taiwan University Hospital |
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Information provided by: | National Taiwan University Hospital |
ClinicalTrials.gov Identifier: | NCT00709046 |
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.
Condition | Intervention |
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Endoscopy Peptic Ulcer Bleeding Proton Pump Inhibitors |
Drug: High dose pantoprazole infusion Drug: Standard dose pantoprazole infusion |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 150 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
High dose pantoprazole infusion
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Drug: High dose pantoprazole infusion
Pantoprazole 80mg iv bolus, 8mg/hr infusion for 72hrs
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2: Active Comparator
standard dose pantoprazole infusion
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Drug: Standard dose pantoprazole infusion
Pantoprazole 40mg iv bolus qd x 3 days
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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.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Chieh-Chang Chen, MD | 886-5-532-3911 ext 2200 | chiehchang.chen@gmail.com |
Taiwan | |
National Taiwan University Hospital | Recruiting |
Taipei, Taiwan | |
Contact: Chieh-Chang Chen, MD 886-5-532-3911 ext 2200 chiehchang.chen@gmail.com |
Responsible Party: | National Taiwan Univeritsy Hospital ( Chieh-Chang Chen ) |
Study ID Numbers: | 200710033M |
Study First Received: | June 30, 2008 |
Last Updated: | July 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00709046 |
Health Authority: | Taiwan: Department of Health |
Endoscopic treatment Peptic ulcer Bleeding Thermocoagulation Proton pump inhibitors |
Stomach Diseases Digestive System Diseases Gastrointestinal Diseases Pantoprazole Ulcer Peptic Ulcer Hemorrhage |
Gastrointestinal Hemorrhage Epinephrine Intestinal Diseases Hemorrhage Duodenal Diseases Peptic Ulcer |
Pathologic Processes Therapeutic Uses Anti-Ulcer Agents Gastrointestinal Agents Pharmacologic Actions |