High-risk Patients for Post-ESD Bleeding Clinical Trial
Official title:
Efficacy of Hemostatic Powder in Preventing Bleeding After Gastric Endoscopic Submucosal Dissection in High-risk Patients: A Prospective Randomized Control Study
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.
A multicenter, prospective, randomized controlled study
- High-risk patients of post-ESD bleeding will be prospectively enrolled in the study.
High-risk of post-ESD bleeding is defined as patients with taking antithrombotic agents
or with large resection (specimen size ≥ 40mm).
- All ESDs were performed according to the standard procedure sequence in the hemostatic
powder group and control group. The Only difference between two groups was hemostatic
powder (Endo-clot™) application after standard hemostasis using hemostatic forceps in
the hemostatic powder 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.
- Bleeding rate of study group within 4 weeks after ESD will be compared with the control
group. "
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