Completed

NCT Number: NCT03169569

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.

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Key information

Conditions

High-risk Patients for Post-ESD Bleeding

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Internal Medicine,

Seoul, 03722, South Korea

About this 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. "

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Older than 19 years old and younger than 85 years old
Pathologically confirmed gastric adenoma and/or early gastric cancer
Iatrogenic gastric ulcer after ESD (Endoscopic submucosal dissection) more than 40mm (at prediction)
Patients who is taking antithrombotic drug such as aspirin and/or coumadin (and other anti-coagulation medication)
ECOG performance status 0 or 1
Adequate renal function (serum creatinine < 1.5 mg/dL or calculated creatinine clearance ≥ 60 ml/min)
Adequate liver function (total bilirubin < 1.5 X the upper limits of normal (ULN), AST and ALT <3 X UNL, and alkaline phosphatases < 3 X ULN or < 5 x ULN in case of liver involvement)
Adequate BM function (WBC ≥ 3,500/µl, absolute neutrophil cell count ≥ 1,500 /µl, platelet count ≥ 100,000/µl)
Subjects who given written informed consent after being given a full description of the study

Exclusion criteria

Previously treated by radical gastrectomy
Adverse effect on this medication
Pregnant or on breast feeding
Patients who are unwilling or unable to provide informed consent, such as those with psychiatric problem, drug abuse or alcoholism

Treatment and study plan

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

Procedure

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.

Other names: Endo-clot™ group

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

Procedure

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

Primary outcomes

Bleeding rate until 4 weeks after ESD

Time frame: until 4 weeks after ESD

Post-ESD bleeding was defined by clinical symptoms or laboratory findings. Clinical symptoms such as melena, hematemesis were defined as bleeding signs. A decrease of hemoglobin of 2.0 g/dL was defined as laboratory bleeding sign.

Secondary outcomes

Bleeding rates according to the timing

Time frame: within 48 hours from 2 days to 4 weeks after ESD

early bleeding: 0~48 hours after ESD late bleeding: 2 days ~ 4 weeks after ESD

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2019
First posted: May 30, 2017
Registry last updated: Mar 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.