Surgicel® Fibrillar for Delayed Bleeding After ESD

Surgicel® (Fibrillar) for Preventing Delayed Bleeding After ESD in Stomach: A Prospective Randomized Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01758965

Enrollment

146

Registered

2013-01-01

Start date

2012-12-31

Completion date

2013-12-31

Last updated

2014-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Neoplasm of Stomach, Malignant Neoplasm of Stomach

Brief summary

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

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

Interventions

OTHERPPI

monotherapy of PPI

OTHERH2RA and surgicel

combination therapy of H2RA and surgicel

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* ESD for gastric dysplasia or early gastric cancer

Exclusion criteria

* Coagulopathy: liver cirrhosis, thrombocytopenia * Anti-platelet agents

Design outcomes

Primary

Measure	Time frame
Delayed bleeding rate after ESD	1 year

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026