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Endoscopic submucosal dissection (ESD) was developed to allow en bloc resection of colorectal neoplasm. Although colorectal ESD has been widely accepted as a minimally invasive treatment option for early colorectal neoplasm, post-ESD bleeding is one of the major adverse events. After ESD procedure, endoscopists close the defects with devices to prevent complications. A novel endoscopic barbed-clips suturing has been developed to simplify endoscopic closure. In this study, the endoscopic barbed-clips will be evaluated when closing defects in the colon after ESD.
Endoscopic submucosal dissection (ESD) has emerged as a new endoscopic technique that allows en-bloc resection of GI lesions, irrespective of size. The most common complications of the ESD techniques are bleeding and perforation. Several reports have shown that if prophylactic closure of a mucosal defect with clips would reduce the risk of bleeding following endoscopic intervention by ESD. With the advancements in endoscopic therapy, various techniques for prevention of post-ESD complications have been reported. However, there have some limitations including their inability to close large defects and the complexity of the approaches and the need for expensive equipment to complete the procedure. To address these issues, we have devised a novel endoscopic barbed-clips suturing method for mucosal defect closure after endoscopic submucosal dissection of colon. In this study, we assessed the technical feasibility of this novel technique.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic Barbed-clips Suturing | Experimental | Patients will be closed the mucosal defect after colorectal ESD using Endoscopic Barbed-clips Suturing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Barbed-clips Suturing | Procedure | Endoscopic Barbed-clips Suturing |
|
| Measure | Description | Time Frame |
|---|---|---|
| The technical success rate | Rate of completely closure of the ESD defect | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic barbed-clips suturing closure time | The time required to close the defect using endoscopic barbed-clips suturing | 1 day |
| Rate of patients reported with bleeding/perforation post-ESD procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yiliang Bi, Dr. | Contact | +8613240439961 | yiliangbi@163.com | |
| Pei Deng, Dr. | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fifth Medical Center of Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100071 | China |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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Conduct follow-ups for risk of bleeding and perforation after closure
| 7 days |
| Clips used post-ESD | Record number of clips needed to close lesion | 7 days |
| The First Medical Center of Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |