Hemospray Versus the Combined Conventional Technique for Endoscopic Hemostasis of Bleeding Peptic Ulcers : A Pilot Study

Not Applicable

Completed

• Conditions: Bleeding Peptic Ulcers
• Interventions: Device: Hemospray; Device: Combined Conventional Technique

• Registration Number: NCT02088385
• Lead Sponsor: Changi General Hospital

Brief Summary

Hemospray (TC-325, Cook Medical Inc, Winston-Salem, NC, USA), a new adsorptive nanopowder hemostatic agent for endoscopic treatment of high-risk bleeding peptic ulcers, provides significant ease of administration compared to the combined conventional technique of saline-adrenaline injection with mechanical clip or heater probe applications. The Hemospray powder is easily applied on ulcers at difficult endoscopic positions and ulcers with fibrotic bases, where the combined conventional technique has limited efficacy. Building up on preliminary work from small single-arm studies, the investigators aim to establish the efficacy and safety of Hemospray in treating bleeding peptic ulcers in comparison with the combined conventional technique. The investigators propose a pilot study to establish our centre's feasibility of performing a prospective, randomized, parallel group trial, which compares the efficacy of Hemospray with the combined conventional technique, in the endoscopic treatment of high-risk bleeding peptic ulcers. Patients with high-risk bleeding peptic ulcers will be treated with Hemospray to determine its initial hemostasis rate (defined as endoscopically verified cessation of bleeding for at least 5 minutes after endoscopic treatment), rebleeding rate (recurrent hemorrhage during a 4-week period following the initial hemostasis) and its safety profile.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-03-13
• Study First Submitted QC: 2014-03-13
• Study First Posted: 2014-03-14
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2019-07
• Results First Submitted: 2019-07-22
• Results First Submitted QC: 2019-07-22
• Last Update Submitted: 2019-07-22
• Results First Posted: 2019-08-29
• Last Update Posted: 2019-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Peptic ulcer with high-risk stigmata of recent hemorrhage (Forrest class IA, IB, IIA and IIB)

Exclusion Criteria

• Patients younger than 21 years of age
• Refusal to participate in study
• Contraindicated for endoscopy
• Pregnant or lactating patients
• Bleeding secondary to non-peptic ulcer source
• Patients requiring mechanical ventilation
• Patients with acute coronary syndrome

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hemospray	Hemospray	Hemospray (TC-325, Cook Medical Inc, Winston-Salem, NC, USA), an adsorptive nanopowder hemostatic agent
Combined Conventional Technique	Combined Conventional Technique	Standard dual therapy with saline adrenaline injection and hemoclip / heater probe application

Primary Outcome Measures

Name	Time	Method
Re-bleeding Within 4 Weeks	4 weeks	* drop in hemoglobin of at least 2 g/dl, associated with overt signs of GI bleed (melena, and/or hematemesis); * fresh blood hematemesis; * melena with a hemodynamic instability (pulse rate \> 100/min, systolic blood pressure \< 90 mm Hg)

Secondary Outcome Measures

Name	Time	Method
Initial Hemostasis Rate	Within first endoscopy session	Endoscopically verified cessation of bleeding for at least 5 minutes after treatment.

Trial Locations

Locations (1)

Changi General Hospital; 🇸🇬 Singapore, Singapore