Resolution Endoclips Vs Epinephrine Injection and Heater Probe
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|ClinicalTrials.gov Identifier: NCT00165009|
Recruitment Status : Terminated (Slow recruitment)
First Posted : September 14, 2005
Last Update Posted : May 13, 2013
|Condition or disease||Intervention/treatment||Phase|
|Peptic Ulcer Hemorrhage||Device: Resolution clip (endo-clipping device)||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||103 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||November 2008|
No Intervention: DUAL THERAPY
Experimental: 'Resolution clip
Device: Resolution clip (endo-clipping device)
Resolution clip (endo-clipping device)
- Failure to control bleeding endoscopically and recurrent bleeding after initial control [ Time Frame: 30 days ]
linical rebleeding is defined by fresh hematemesis, fresh melena or hematochezia and signs of hypovolemic shock (systolic blood pressure of <90mmHg and pulse rate >110 per minute) and a drop in hemoglobin of > 2 g/dl per 24 hours despite adequate transfusion.
Rebleeding will be confirmed by an immediate endoscopy showing fresh blood in stomach or active bleeding from a previously seen ulcer. A clinical rebleeding will be independently reviewed by an adjudication panel.
- Transfusion requirement (before and after endoscopic therapy) [ Time Frame: within 30 days of therapy ]
- Hospital stay [ Time Frame: within 30 days of therapy ]
- The need for surgery [ Time Frame: within 30 days of therapy ]
- Mortality from recurrent bleeding and all causes within 30 days of treatment [ Time Frame: within 30 days of therapy ]
- Treatment related complications e.g. perforation [ Time Frame: within 30 days of therapy ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00165009
|Endocopy Center, Prince of Wales Hospital|
|Hong Kong SAR, China|
|Principal Investigator:||Justin C Wu, MD||Endoscopy Center, Prince of Wales Hospital|