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A prospective, single-center, open-label, randomized controlled phase 2 study to evaluate the efficacy of fibrin glue (Greenplast) to prevent post-procedural bleeding after endoscopic submucosal dissection for stomach neoplasms

A prospective, single-center, open-label, randomized controlled phase 2 study to evaluate the efficacy of fibrin glue (Greenplast) to prevent post-procedural bleeding after endoscopic submucosal dissection for stomach neoplasms

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010131
Enrollment
252
Registered
2025-01-10
Start date
2021-07-09
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

None listed

Interventions

Sponsors

Samsung Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Patients with a history of allergies to fibring or administrative prohibitions among PPI's licensed items. Patients who are scheduled to receive ESD for Multiplexion. Pregnant or breastfeeding People with acute or acquired hemorrhagic diseases.

Design outcomes

Primary

MeasureTime frame
Total bleeding rate within 60 days of post-treatment

Secondary

MeasureTime frame
Rate of post-treatment bleeding in ESD patients with non-stop and temporarily suspended anticoagulant anticoagulants

Countries

Korea, Republic of

Contacts

Public ContactMin Yangwon

Samsung Medical Center

pk5419@naver.com+82-2-3410-3000

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026