An Endoscopic Barbed-clips Suturing for Colorectal ESD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-20

Study Completion Date

2021-12-20

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.

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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.

Conditions

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Colorectal Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endoscopic Barbed-clips Suturing

Patients will be closed the mucosal defect after colorectal ESD using Endoscopic Barbed-clips Suturing.

Group Type EXPERIMENTAL

Endoscopic Barbed-clips Suturing

Intervention Type PROCEDURE

Endoscopic Barbed-clips Suturing

Interventions

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Endoscopic Barbed-clips Suturing

Intervention Type PROCEDURE

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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No