An Endoscopic Barbed-clips Suturing for Colorectal ESD

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Novel Endoscopic Barbed-clips Suturing for Mucosal Defect Closure After Endoscopic Submucosal Dissection of Colon

Conditions
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Colorectal Neoplasms

Intervention / Treatment
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* Procedure: Endoscopic Barbed-clips Suturing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged≥20 years with a single clinically or histologically diagnosed colorectal lesions of 20-50mm eligible for which fulfilled criteria for ESD; Exclusion Criteria: Patients with coagulopathy (platelet count < 5 × 10*4, prothrombin time international normalized ratio > 2, medical conditions requiring the continuous use of antithrombotic agents prior abdominal surgery or radiation.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoscopic Barbed-clips Suturing<br>Patients will be closed the mucosal defect after colorectal ESD using Endoscopic Barbed-clips Suturing. | Procedure: Endoscopic Barbed-clips Suturing<br>* Endoscopic Barbed-clips Suturing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The technical success rate | Rate of completely closure of the ESD defect | 1 day | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |