Resolution Endoclips Vs Epinephrine Injection and Heater Probe

Peptic Ulcer Hemorrhage Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00165009
• Other study ID #: RET
• Status: Terminated
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: May 10, 2013
• Start date: June 2005
• Est. completion date: November 2008

Study information

• Verified date: May 2013
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 103
• Est. completion date: November 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peptic Ulcer
• Peptic Ulcer Hemorrhage

Intervention

Device:
• Resolution clip (endo-clipping device)
Resolution clip (endo-clipping device)

Locations

Country	Name	City	State
China	Endocopy Center, Prince of Wales Hospital	Hong Kong SAR

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Transfusion requirement (before and after endoscopic therapy)		within 30 days of therapy	No
Secondary	Hospital stay		within 30 days of therapy	No
Secondary	The need for surgery		within 30 days of therapy	No
Secondary	Mortality from recurrent bleeding and all causes within 30 days of treatment		within 30 days of therapy	No
Secondary	Treatment related complications e.g. perforation		within 30 days of therapy	No