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Resolution Endoclips Vs Epinephrine Injection and Heater Probe
This study has been terminated.
Study NCT00165009   Information provided by Chinese University of Hong Kong
First Received: September 12, 2005   Last Updated: October 26, 2006   History of Changes

September 12, 2005
October 26, 2006
June 2005
 
Failure to control bleeding endoscopically and recurrent bleeding after initial control
Same as current
Complete list of historical versions of study NCT00165009 on ClinicalTrials.gov Archive Site
  • 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
Same as current
 
Resolution Endoclips Vs Epinephrine Injection and Heater Probe
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

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

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.

Phase III
Interventional
Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Peptic Ulcer Hemorrhage
Device: Resolution clip (endo-clipping device)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
948
August 2006
 

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00165009
 
RET
Chinese University of Hong Kong
 
Principal Investigator: Justin C Wu, MD Endoscopy Center, Prince of Wales Hospital
Chinese University of Hong Kong
October 2006

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