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

NCT ID: NCT02625792

Last Updated: 2017-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-10-31

Brief Summary

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.

Conditions

Iatrogenic Ulcer After ESD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Endo-Clot(TM)

The intervention group

Group Type: EXPERIMENTAL

Endo-Clot(TM)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yonsei university of medical center

Seoul, Seoul, South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 28910851 (View on PubMed)

Other Identifiers

4-2015-0925

Identifier Type: -

Identifier Source: org_study_id