Clinical trial NCT00165009: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Peptic Ulcer Hemorrhage
Keywords: Bleeding Peptic Ulcer
Endoscopic treatment
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 103
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Failure to control bleeding endoscopically and recurrent bleeding after initial control
timeFrame: 30 days
Secondary outcomes:
measure: Transfusion requirement (before and after endoscopic therapy)
timeFrame: within 30 days of therapy
measure: Hospital stay
timeFrame: within 30 days of therapy
measure: The need for surgery
timeFrame: within 30 days of therapy
measure: Mortality from recurrent bleeding and all causes within 30 days of treatment
timeFrame: within 30 days of therapy
measure: Treatment related complications e.g. perforation
timeFrame: within 30 days of therapy
Other outcomes:
Locations:
city: Hong Kong SAR
country: China
facility: Endocopy Center, Prince of Wales Hospital
Study officials:
affiliation: Endoscopy Center, Prince of Wales Hospital
name: Justin C Wu, MD
role: PRINCIPAL_INVESTIGATOR
References: