Resolution Endoclips Vs Epinephrine Injection and Heater Probe - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

October 26, 2006

Start Date ^ICMJE

June 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Failure to control bleeding endoscopically and recurrent bleeding after initial control

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00165009 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Resolution Endoclips Vs Epinephrine Injection and Heater Probe

Official Title ^ICMJE

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

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Peptic Ulcer Hemorrhage

Intervention ^ICMJE

Device: Resolution clip (endo-clipping device)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

948

Completion Date

August 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT ID ^ICMJE

NCT00165009

Responsible Party

Study ID Numbers ^ICMJE

RET

Study Sponsor ^ICMJE

Chinese University of Hong Kong

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Justin C Wu, MD

Endoscopy Center, Prince of Wales Hospital

Information Provided By

Chinese University of Hong Kong

Verification Date

October 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP