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| Name | Class |
|---|---|
| Seoul National University Bundang Hospital | OTHER |
| Severance Hospital | OTHER |
| Asan Medical Center | OTHER |
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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.
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 Qâ„¢) 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibrin glue group | Experimental | Spread Fibrin glue(Greenplast Qâ„¢) at iatrogenic ulcer after gastric ESD |
|
| Control group | No Intervention | No intervention after gastric ESD |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human fibrinogen concentrate | Drug | Spread the Human fibrinogen concentrate/Aprotinin/Thrombin/Calcium chloride hydrate mixture on iatrogenic ulcer after ESD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding after ESD | Number of gastrointestinal bleeding events within 4 weeks after the procedure | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Early bleeding after ESD | Number of gastrointestinal bleeding events within 48 hours after the procedure | 48 hours |
| Delayed bleeding after ESD | Number of gastrointestinal bleeding events from 48 hours to 4 weeks after the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eunwoo Lee, M.D. | fellowship | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36594814 | Derived | 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. |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| from 48 hours to 4 weeks |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |