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Completed

NCT Number: NCT01758965

Surgicel® Fibrillar for Delayed Bleeding After ESD

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

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Key information

Conditions

Benign Neoplasm of Stomach Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Malignant Neoplasm of Stomach Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Bucheon-si, Gyeonggi-do, 420-767, South Korea

About this study

  • Patient (1) Inclusion: Diagnosed as gastric dysplasia or early gastric cancer
  • Scheduled for ESD (2) Exclusion: Coagulopathy- liver cirrhosis, thrombocytopenia
  • Anti-platelet agents
  • Method

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

  • Primary endpoint: rate of delayed bleeding after ESD
  • Secondary endpoint: follow-up hemoglobin after ESD

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ESD for gastric dysplasia or early gastric cancer

Exclusion criteria

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

Treatment and study plan

PPI

Other

monotherapy of PPI

H2RA and surgicel

Other

combination therapy of H2RA and surgicel

Primary outcomes

  1. Delayed bleeding rate after ESD

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Soonchunhyang University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 1, 2013
Registry last updated
May 13, 2014

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.

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