Efficacy of Hemostatic Powder in Preventing Bleeding After Gastric Endoscopic Submucosal Dissection in High-risk Patients: A Prospective Randomized Control Study
Condition: High-risk Patients for Post-ESD Bleeding
MeSH terms: Hemorrhage
Study type: Interventional

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.
    

Detailed description: 
      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. "
    

Intervention name(s): Endo-clot™ (EndoClot Plus, Unc., Santa Clara, CA, USA) group; Hemostatic forceps Only (Coagrasper®, Olympus, Japan) group
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; All ESDs were performed according to the standard procedure sequence in the hemostatic group and control group except hemostatic powder application.
Other intervention name(s): Endo-clot™ group
Intervention MeSH terms: Hemostatics
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All procedures 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.
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: hemostatic powder; post-ESD bleeding; antithrombotic therapy; high risk of bleeding; endoscopic submucosal dissection; adverse event