Effectiveness of fibrin glue to prevent bleeding in high-risk patients after endoscopic submucosal dissection in gastric neoplasm : A prospective randomized controlled study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0006000

Enrollment

254

Registered

2021-03-16

Start date

2020-11-16

Completion date

Unknown

Last updated

2024-03-04

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

Conditions

None listed

Interventions

Drug : Spread the Human fibrinogen concentrate/Aprotinin/Thrombin/Calcium chloride hydrate mixture on iatrogenic ulcer after ESD or not

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 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

Design outcomes

Primary

Measure	Time frame
Number of gastrointestinal bleeding events within 4 weeks after the procedure	—

Secondary

Measure	Time frame
Number of gastrointestinal bleeding events within 48 hours after the procedure;Number of gastrointestinal bleeding events from 48 hours to 4 weeks after the procedure	—

Countries

Korea, Republic of

Contacts

Public ContactEunwoo Lee

Seoul National University Hospital

rfsquid@naver.com+82-2-2072-2228

Outcome results