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Sponsored by: |
Chinese University of Hong Kong |
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Information provided by: | Chinese University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT00165009 |
To compare the efficacy of a novel endoscopic clipping device(Resolution Clip™) and conventional epinephrine injection and heater probe thermocoagulation in control of peptic ulcer bleeding and prevention of recurrent bleeding
Condition | Intervention | Phase |
---|---|---|
Peptic Ulcer Hemorrhage |
Device: Resolution clip (endo-clipping device) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Prospective Randomized Comparison of a Novel Hemostatic Clip (Resolution Clip™) to Combined Epinephrine Injection and Heater Probe Thermocoagulation in the Endoscopic Control of Ulcer Bleeding |
Estimated Enrollment: | 948 |
Study Start Date: | June 2005 |
Estimated Study Completion Date: | August 2006 |
The mortality of peptic ulcer bleeding remains high despite advances in endoscopy and medical therapy. Endoscopic therapy effectively controls peptic ulcer bleeding and substantially reduces recurrent bleeding. However, the best endoscopic therapy is still unclear. The current standard of therapy is injection with diluted epinephrine and heater probe (3.2mm) thermo-coagulation. However, it may be associated with complications such as precipitation of myocardial ischemia or heater probe perforation. Endoscopic clipping is an emerging modality of endoscopic treatment, it mimics the use of surgical ligature on bleeding artery. Endo-clipping has the theoretical advantage over injection and heater probe in that the tissue reaction or damage will be much milder.
Resolution Clip™ is a newly developed endo-clipping device. It is superior to older generations of endo-clips in that it allows repeated closures and re-opening of clip so as to facilitate accurate deployment onto bleeding artery to ensure its optimal placement for hemostasis.
Consecutive patients with endoscopically confirmed bleeding peptic ulcer will be invited to participate in this double-blind, randomised trial, which compares the efficacy of Resolution clip and conventional dual endoscopic therapy. Patients will be compared for 30-day treatment failure rate.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
China | |
Endocopy Center, Prince of Wales Hospital | |
Hong Kong SAR, China |
Principal Investigator: | Justin C Wu, MD | Endoscopy Center, Prince of Wales Hospital |
Study ID Numbers: | RET |
Study First Received: | September 12, 2005 |
Last Updated: | October 26, 2006 |
ClinicalTrials.gov Identifier: | NCT00165009 History of Changes |
Health Authority: | Hong Kong: Department of Health |
Bleeding Peptic Ulcer Endoscopic treatment |
Neurotransmitter Agents Adrenergic alpha-Agonists Adrenergic beta-Agonists Adrenergic Agents Gastrointestinal Diseases Ulcer Gastrointestinal Hemorrhage Anti-Asthmatic Agents Cardiovascular Agents Hemorrhage Intestinal Diseases Adrenergic Agonists |
Hemostatics Digestive System Diseases Stomach Diseases Mydriatics Peptic Ulcer Hemorrhage Vasoconstrictor Agents Peripheral Nervous System Agents Epinephrine Bronchodilator Agents Peptic Ulcer Duodenal Diseases |
Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Gastrointestinal Diseases Physiological Effects of Drugs Hemorrhage Adrenergic Agonists Stomach Diseases Pathologic Processes Peptic Ulcer Hemorrhage Therapeutic Uses Vasoconstrictor Agents Epinephrine Duodenal Diseases |
Peptic Ulcer Adrenergic alpha-Agonists Adrenergic beta-Agonists Sympathomimetics Ulcer Gastrointestinal Hemorrhage Anti-Asthmatic Agents Cardiovascular Agents Intestinal Diseases Pharmacologic Actions Mydriatics Digestive System Diseases Autonomic Agents Peripheral Nervous System Agents Bronchodilator Agents |