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Completed

NCT Number: NCT04602689

Fibrin Glue After ESD for High Risk Patients of Bleeding

It is a prospective randomized controlled study to look for effectiveness of fibrin glue to prevent bleeding in high-risk patients after endoscopic submucosal dissection in gastric neoplasm.

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Key information

Age range

19 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

Investigators want to observe the bleeding rate after endoscopic submucosal dissection for gastric tumors in the high-risk group of bleeding (the size of the iatrogenic ulcer is expected to be 40mm or more, or taking aspirin, antiplatelet drugs, and anticoagulants).

After resection and hemostasis with ESD, Fibrin glue (Greenplast Q™) is applied to the iatrogenic ulcer at the end of the procedure, and the control group will not be applied.

After that, observe whether there is a difference in the bleeding rate within 48 hours and 4 weeks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ECOG performance status 0-1
  • Patients scheduled to undergo ESD due to gastric tumor (dysplasia, early gastric cancer)
  • Patients who are expected to have an iatrogenic ulcer size of 40mm or more after endoscopic submucosal dissection, or are taking aspirin, antiplatelet drugs, or anticoagulants
  • Patients who show adequate patient compliance and have adequate geographic distance for follow-up observation.

Exclusion criteria

  • Patients with sensitivity to cow protein or its derived ingredients
  • Patients who had previously undergone partial gastrectomy
  • Patients with early gastric cancer at the site previously undergoing ESD
  • Patients with clinically significant cardiopulmonary disease
  • Patients with active hepatitis, liver disease that is not well controlled by treatment, or severe liver disorder
  • Patients with severe renal impairment
  • Patients with severe bone marrow dysfunction
  • Patients with severe blood clotting impairment (including hemophilia)
  • Patients with serious neurological or mental illness (e.g. epilepsy or dementia)
  • Patients with reported side effects of contrast media
  • Pregnant and lactating women
  • Patients who have not obtained the informed consent of the patient and guardian
  • Patients who are inadequate for clinical trials as judged by the attending physician

Treatment and study plan

Human fibrinogen concentrate

Drug

Spread the Human fibrinogen concentrate/Aprotinin/Thrombin/Calcium chloride hydrate mixture on iatrogenic ulcer after ESD

Primary outcomes

  1. Bleeding after ESD

    Time frame: 4 weeks

    Number of gastrointestinal bleeding events within 4 weeks after the procedure

Secondary outcomes

  1. Early bleeding after ESD

    Time frame: 48 hours

    Number of gastrointestinal bleeding events within 48 hours after the procedure

  2. Delayed bleeding after ESD

    Time frame: from 48 hours to 4 weeks

    Number of gastrointestinal bleeding events from 48 hours to 4 weeks after the procedure

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Asan Medical Center
  • Seoul National University Bundang Hospital
  • Severance Hospital

Registry information

Official study title

Effectiveness of Fibrin Glue to Prevent Bleeding in High-risk Patients After Endoscopic Submucosal Dissection in Gastric Neoplasm : A Prospective Randomized Controlled Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 26, 2020
Registry last updated
Nov 29, 2024

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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