Resolution Endoclips Vs Epinephrine Injection and Heater Probe

Phase 3

Terminated

• Conditions: Peptic Ulcer Hemorrhage
• Interventions: Device: Resolution clip (endo-clipping device)

• Registration Number: NCT00165009
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-14
• Primary Completion: 2008-01
• Study Completion: 2008-11
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-10
• Last Update Posted: 2013-05-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

• Age >16 , can obtain written consent
• Ulcers that require endoscopic therapy with SRH: Forrest I a, Ib, II a and II b

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
'Resolution clip	Resolution clip (endo-clipping device)	'Resolution clip

Primary Outcome Measures

Name	Time	Method
Failure to control bleeding endoscopically and recurrent bleeding after initial control	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.

Secondary Outcome Measures

Name	Time	Method
The need for surgery	within 30 days of therapy
Transfusion requirement (before and after endoscopic therapy)	within 30 days of therapy
Hospital stay	within 30 days of therapy
Mortality from recurrent bleeding and all causes within 30 days of treatment	within 30 days of therapy
Treatment related complications e.g. perforation	within 30 days of therapy

Trial Locations

Locations (1)

Endocopy Center, Prince of Wales Hospital; 🇨🇳 Hong Kong SAR, China