Role of Hemostatic Powder (Endo-clotTM) in Prevention of Bleeding Within High Risk Patients After ESD

SD has become a standard treatment of gastric neoplasm confined to mucosa(epithelium). But after procedure, formation of iatrogenic gastric ulcer is inevitable. And Post ESD ulcer bleeding rate reported about 5% ~ 10% of all cases. Antiplatelet or anti-coagulation treatment might be associated higher incidence of rebleeding after ESD and iatrogenic ulcer bigger than 40mm in size is also associated.

Though several previous study have failed to show efficacy of 2nd look EGD, but those reports pointed out that visible vessels with current bleeding or highly suspect of recent bleeding (Forrest type IA~IIB) was observed about 10~20% of patients. Such patients are at high risk of bleeding.

So, Investigators hypothesize that appliance of Endo-Clot(TM) at post ESD ulcer have a significant role of protection from gastric acidic juice and help mucosa heal earlier. Thus visible vessels with risk of bleeding is going to be rarely observed at 2nd look EGD. And finally this protective effect might have an effect for prophylaxis of post ESD ulcer bleeding.

Study Overview

• Status: Completed
• Conditions: Iatrogenic Ulcer After ESD
• Intervention / Treatment: Drug: Endo-Clot(TM)

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Yonsei university of medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

A. Older than 19 years old and younger than 80 years old B. Pathologically confirmed gastric adenoma and/or early gastric cancer C. Iatrogenic gastric ulcer after ESD(Endoscopic submucosal dissection) more than 40mm (at prediction) D. Patients who is taking medication such at aspirin and/or coumadin (and other anti-coagulation medication) E. ECOG performance status 0 or 1 F. Adequate renal function (serum creatinine < 1.5 mg/dL or calculated creatinine clearance ≥ 60 ml/min) G. 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) H. Adequate BM function (WBC ≥ 3,500/µl, absolute neutrophil cell count ≥ 1,500 /µl, platelet count ≥ 100,000/µl) I. Subjects who given written informed consent after being given a full description of the study

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endo-Clot(TM); The intervention group	Drug: Endo-Clot(TM); After patients treated with ESD, Hemostatic power was applied on the post-resection surface by Endo-Clot™ system. And treated with proton pump inhibitor as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the bleeding rate until 4 weeks after ESD	Post-ESD bleeding was defined by clinical symptoms or laboratory findings. Clinical symptoms such as melena or hematemesis were defined as bleeding signs.	POD ~ 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forrest classification of the post-resection ulcer at 48 hours after ESD	On POD 2, patients underwent scheduled second-look endoscopy 48 hours after ESD. The artificial ulcer induced by ESD was evaluated and classified according to the Forrest classification.	POD 2
the bleeding rates according to timing and subgroup	the bleeding rate until 4 weeks after ESD: Post-ESD bleeding was defined by clinical symptoms or laboratory findings. Clinical symptoms such as melena or hematemesis were defined as bleeding signs. (Acute bleeding: within 48 hours after ESD & Delayed bleeding: beyond 48 hours after ESD)	POD 0 ~ 4 weeks

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General Publications

• Hahn KY, Park JC, Lee YK, Shin SK, Lee SK, Lee YC. Efficacy of hemostatic powder in preventing bleeding after gastric endoscopic submucosal dissection in high-risk patients. J Gastroenterol Hepatol. 2018 Mar;33(3):656-663. doi: 10.1111/jgh.13990.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: December 6, 2015
• First Submitted That Met QC Criteria: December 8, 2015
• First Posted (Estimate): December 9, 2015

Study Record Updates

• Last Update Posted (Estimate): January 9, 2017
• Last Update Submitted That Met QC Criteria: January 5, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Bleeding; Prophylaxis; Post ESD ulcer
• Other Study ID Numbers: 4-2015-0925

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will be not shared and used only for this study