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

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 Intervention Phase
Peptic Ulcer Hemorrhage
Device: Resolution clip (endo-clipping device)
Phase III

MedlinePlus related topics: Endoscopy Peptic Ulcer
Drug Information available for: Epinephrine bitartrate Epinephrine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Chinese University of Hong Kong:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 948
Study Start Date: June 2005
Estimated Study Completion Date: August 2006
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00165009

Locations
China
Endocopy Center, Prince of Wales Hospital
Hong Kong SAR, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Justin C Wu, MD Endoscopy Center, Prince of Wales Hospital
  More Information

No publications provided

Study ID Numbers: RET
Study First Received: September 12, 2005
Last Updated: October 26, 2006
ClinicalTrials.gov Identifier: NCT00165009     History of Changes
Health Authority: Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:
Bleeding Peptic Ulcer
Endoscopic treatment

Study placed in the following topic categories:
Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Adrenergic Agents
Gastrointestinal Diseases
Ulcer
Gastrointestinal Hemorrhage
Anti-Asthmatic Agents
Cardiovascular Agents
Hemorrhage
Intestinal Diseases
Adrenergic Agonists
Hemostatics
Digestive System Diseases
Stomach Diseases
Mydriatics
Peptic Ulcer Hemorrhage
Vasoconstrictor Agents
Peripheral Nervous System Agents
Epinephrine
Bronchodilator Agents
Peptic Ulcer
Duodenal Diseases

Additional relevant MeSH terms:
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Gastrointestinal Diseases
Physiological Effects of Drugs
Hemorrhage
Adrenergic Agonists
Stomach Diseases
Pathologic Processes
Peptic Ulcer Hemorrhage
Therapeutic Uses
Vasoconstrictor Agents
Epinephrine
Duodenal Diseases
Peptic Ulcer
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Sympathomimetics
Ulcer
Gastrointestinal Hemorrhage
Anti-Asthmatic Agents
Cardiovascular Agents
Intestinal Diseases
Pharmacologic Actions
Mydriatics
Digestive System Diseases
Autonomic Agents
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on May 06, 2009