Clinical Trial: Resolution Endoclips Vs Epinephrine Injection and Heater Probe

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Chinese University of Hong Kong

Current Primary Outcome: Failure to control bleeding endoscopically and recurrent bleeding after initial control [ Time Frame: 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.



Original Primary Outcome: Failure to control bleeding endoscopically and recurrent bleeding after initial control

Current Secondary Outcome:

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


Original Secondary Outcome:

  • 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


Information By: Chinese University of Hong Kong

Dates:
Date Received: September 12, 2005
Date Started: June 2005
Date Completion:
Last Updated: May 10, 2013
Last Verified: May 2013