Surgicel® Fibrillar for Delayed Bleeding After ESD

NCT ID: NCT01758965

Last Updated: 2014-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-12-31

Brief Summary

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The aim of this study is to assess the effect of Surgicel® Fibrillar as adjuvant treatment to H2RA on preventing ulcer bleeding after ESD for gastric epithelial tumors

Detailed Description

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1. Patient (1) Inclusion: Diagnosed as gastric dysplasia or early gastric cancer

* Scheduled for ESD (2) Exclusion: Coagulopathy- liver cirrhosis, thrombocytopenia
* Anti-platelet agents
2. Method

(1) Study group: combination with Surgicel® Fibrillar and H2RA (2) Control group: monotherapy with PPI 3. Sample size : 157 4. Result

1. Primary endpoint: rate of delayed bleeding after ESD
2. Secondary endpoint: follow-up hemoglobin after ESD

Conditions

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Benign Neoplasm of Stomach Malignant Neoplasm of Stomach

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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combination therapy of H2RA and surgicel

H2RA and surgicel

Group Type EXPERIMENTAL

H2RA and surgicel

Intervention Type OTHER

combination therapy of H2RA and surgicel

Monotherapy of PPI

PPI

Group Type EXPERIMENTAL

PPI

Intervention Type OTHER

monotherapy of PPI

Interventions

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PPI

monotherapy of PPI

Intervention Type OTHER

H2RA and surgicel

combination therapy of H2RA and surgicel

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ESD for gastric dysplasia or early gastric cancer

Exclusion Criteria

* Coagulopathy: liver cirrhosis, thrombocytopenia
* Anti-platelet agents
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Soonchunhyang University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Su Jin Hong

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine

Bucheon-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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MD_SCHBC_IRB_2012-06

Identifier Type: -

Identifier Source: org_study_id

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