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| Descriptive Information Fields | |||||
| Brief Title † | Resolution Endoclips Vs Epinephrine Injection and Heater Probe | ||||
| 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 | ||||
| Brief Summary | 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 |
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| Detailed Description | 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. |
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| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | Failure to control bleeding endoscopically and recurrent bleeding after initial control | ||||
| Secondary Outcome Measure † | Transfusion requirement (before and after endoscopic therapy) Hospital stay The need for surgery Mortality from recurrent bleeding and all causes within 30 days of treatment Treatment related complications e.g. perforation |
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| Condition † | Peptic Ulcer Hemorrhage | ||||
| Intervention † | Device: Resolution clip (endo-clipping device) | ||||
| MEDLINE PMIDs | |||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Terminated | ||||
| Enrollment † | 948 | ||||
| Start Date † | June 2005 | ||||
| Completion Date | August 2006 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 16 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | China | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00165009 | ||||
| Organization ID | RET | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Chinese University of Hong Kong | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Chinese University of Hong Kong | ||||
| Verification Date | October 2006 | ||||
| First Received Date † | September 12, 2005 | ||||
| Last Updated Date | October 26, 2006 | ||||
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