Resolution Endoclips Vs Epinephrine Injection and Heater Probe
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Age >16 , can obtain written consent
- Ulcers that require endoscopic therapy with SRH: Forrest I a, Ib, II a and II b
Exclusion criteria
- Moribund patients with terminal malignancy
- Pregnancy
- Intercurrent ulcer complication that prevents treatment and surgery becomes mandatory such as bulbar stenosis and ulcer perforation
Trial design
Primary purpose
Allocation
Interventional model
Masking
103 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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