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Endoscopic submucosal dissection (ESD) is an important minimally invasive treatment method for early digestive tract tumors, with a high cure rate, and it is widely used in clinical practice. And wound closure after ESD is a great challenge, which is closely related to postoperative perforation bleeding. Clip closure is one of the most commonly used closure methods. However, when the wound is large or when the wound is located more difficult to operate, conventional closure may lead to delayed perforation, and postoperative clips may be prone to early spontaneous shedding. The authors have recently reported a method that may be able to close larger and difficult wounds because the grooves can better fix the metal clips. The latest study suggests that this approach may be safe and effective, but the study has a small sample size and has no controls. Therefore, high-quality clinical study evidence related to punch closure is required in the strategy of defect closure after ESD, in order to better evaluate the feasibility and safety of this new endoscopic closure method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| punching closure | Experimental | punching closure for defect closure after ESD |
|
| Conventional clipping | Active Comparator | Conventional clipping for defect closure after ESD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| punching closure | Other | The hole clamping and the grooves hold the metal clips better |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Completely closed | The wound is completely closed without dehiscence | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| delayed hemorrhage | Any symptoms of gastrointestinal bleeding (e. g. hematochezia) occurred within 30 days after polypectomy and were classified as mild or severe according on the severity of the bleeding | 2 weeks and 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Xu | Contact | +8613486659126 | xulei22@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ningbo first hospital | Recruiting | Ningbo | Zhejiang | China |
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| Conventional clipping |
| Other |
Metal lip closure is one of the most commonly used closure methods |
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