An Endoscopic Barbed-clips Suturing for Colorectal ESD

Not Applicable

• Conditions: Colorectal Neoplasms
• Interventions: Procedure: Endoscopic Barbed-clips Suturing

• Registration Number: NCT05045911
• Lead Sponsor: Affiliated Hospital to Academy of Military Medical Sciences

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-08-17
• Status Verified: 2021-09
• Study First Submitted QC: 2021-09-14
• Last Update Submitted: 2021-09-14
• Study First Posted: 2021-09-16
• Last Update Posted: 2021-09-16
• Study Start: 2021-09-20
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The technical success rate	1 day	Rate of completely closure of the ESD defect

Secondary Outcome Measures

Name	Time	Method
Endoscopic barbed-clips suturing closure time	1 day	The time required to close the defect using endoscopic barbed-clips suturing
Clips used post-ESD	7 days	Record number of clips needed to close lesion
Rate of patients reported with bleeding/perforation post-ESD procedure	7 days	Conduct follow-ups for risk of bleeding and perforation after closure

Trial Locations

Locations (2)

The Fifth Medical Center of Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China

The First Medical Center of Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China