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

Study Overview

• Status: Terminated
• Conditions: Peptic Ulcer Hemorrhage
• Intervention / Treatment: Device: Resolution clip (endo-clipping device)

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 Type: Interventional
• Enrollment (Actual): 103
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Hong Kong SAR, China
    • Endocopy Center, Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: DUAL THERAPY
Experimental: 'Resolution clip	Device: Resolution clip (endo-clipping device); Resolution clip (endo-clipping device)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Failure to control bleeding endoscopically and recurrent bleeding after initial control	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.	30 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Justin C Wu, MD, Endoscopy Center, Prince of Wales Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 14, 2005

Study Record Updates

• Last Update Posted (Estimate): May 13, 2013
• Last Update Submitted That Met QC Criteria: May 10, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Endoscopic treatment; Bleeding Peptic Ulcer
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Duodenal Diseases; Gastrointestinal Hemorrhage; Ulcer; Hemorrhage; Peptic Ulcer; Peptic Ulcer Hemorrhage
• Other Study ID Numbers: RET