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Resolution Endoclips Vs Epinephrine Injection and Heater Probe

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00165009
Recruitment Status : Terminated (Slow recruitment)
First Posted : September 14, 2005
Last Update Posted : May 13, 2013
Information provided by (Responsible Party):
James Yun-wong Lau, 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

Condition or disease Intervention/treatment Phase
Peptic Ulcer Hemorrhage Device: Resolution clip (endo-clipping device) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : June 2005
Actual Primary Completion Date : January 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: DUAL THERAPY
Experimental: 'Resolution clip
'Resolution clip
Device: Resolution clip (endo-clipping device)
Resolution clip (endo-clipping device)

Primary Outcome Measures :
  1. 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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00165009

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Endocopy Center, Prince of Wales Hospital
Hong Kong SAR, China
Sponsors and Collaborators
Chinese University of Hong Kong
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Principal Investigator: Justin C Wu, MD Endoscopy Center, Prince of Wales Hospital
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Responsible Party: James Yun-wong Lau, Professor, Chinese University of Hong Kong Identifier: NCT00165009    
Other Study ID Numbers: RET
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: May 13, 2013
Last Verified: May 2013
Keywords provided by James Yun-wong Lau, Chinese University of Hong Kong:
Bleeding Peptic Ulcer
Endoscopic treatment
Additional relevant MeSH terms:
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Peptic Ulcer
Peptic Ulcer Hemorrhage
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gastrointestinal Hemorrhage