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Efficacy of Hemostatic Powder in Preventing Bleeding After Gastric Endoscopic Submucosal Dissection in High-risk Patients: A Prospective Randomized Control Study

NCT03169569 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2020-03-17

No results posted yet for this study

Summary

Endoscopic submucosal dissection (ESD) for superficial gastric neoplasm is minimally invasive and achieves curative resection with an acceptable rate of adverse events. Although the safety of ESD has been demonstrated, the procedure is associated with a substantial risk of adverse events, including bleeding, perforation, and stricture.

Post-ESD bleeding is the most frequent adverse events and the incidence of post-ESD bleeding in previous studies ranges from 1.8% to 15.6%. Several studies identified that antithrombotic agents and large resection size were strong risk factors for post-ESD bleeding. Moreover, the incidence of bleeding in high-risk patients has been reported to be as high as 61.5%, depending on the definition of high-risk patients. The number of patients at high risk for post-ESD bleeding is increasing worldwide. In addition, as the indications for ESD have been expanding, more patients with large lesions undergo ESD. Therefore, it is important to prevent post-ESD bleeding in high-risk patients.

Although several previous studies have attempted to prevent post-ESD bleeding using surgical material, there is no definite prophylactic treatment to prevent re-bleeding after ESD. To date, coagulation of remnant vessels on the post-resection ulcer surface and administration of a proton pump inhibitor (PPI) after ESD are practical methods to prevent post-ESD bleeding.

Polysaccharide hemostatic powder (Endo-Clot™) is a new topical hemostatic method recently used for non-variceal upper gastrointestinal bleeding. This study aimed to identify the efficacy of hemostatic powder in preventing post-ESD bleeding in high-risk patients. This is a multicenter, prospective, randomized study.

Conditions

  • High-risk Patients for Post-ESD Bleeding

Interventions

PROCEDURE

Endo-clot™ (EndoClot Plus, Unc., Santa Clara, CA, USA) group

For patients in the study group, after hemostasis on the post-resection ulcer using conventional method and removal of specimen, Endo-clot™ (EndoClot Plus, Unc., Santa Clara, CA, USA) was applied immediately onto the post-resection surface.

PROCEDURE

Hemostatic forceps Only (Coagrasper®, Olympus, Japan) group

All ESDs were performed according to the standard procedure sequence in the hemostatic group and control group except hemostatic powder application.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2018-09-25
Completion
2019-05-09

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03169569 on ClinicalTrials.gov