Fibrin Glue After ESD for High Risk Patients of Bleeding

Completed 134 enrolled Seoul National University Hospital Asan Medical Center · collab Seoul National University Bundang Hospital · collab Severance Hospital · collab

RandomizedParallel-groupSingle-blindTreatment

Summary

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.

Timeline

Start: 2020-10-30
Primary completion: 2022-07-14
Completion: 2022-07-14

Outcome

Missed primary endpoint

paper This trial failed to show a preventive effect of fibrin glue on overall post-ESD bleeding in high-risk patients. PMID 36594814 ↗

Publications

Lee HD, Lee E, Kim SG, Shin CM, Park JC, Choi KD, Hahn S, Cho SJ. A Randomized Controlled Trial of Fibrin Glue to Prevent Bleeding After Gastric Endoscopic Submucosal Dissection. Am J Gastroenterol. 2023 May 1;118(5):892-899. doi: 10.14309/ajg.0000000000002172. Epub 2022 Dec 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aprotinin	Unknown	—	Topical
Subject	Calcium chloride hydrate	Unknown	—	Topical
Subject	Human fibrinogen concentrate	Protein / enzyme biologic	—	Topical
Subject	thrombin	Protein / enzyme biologic	—	Topical