An Endoscopic Barbed-clips Suturing for Colorectal ESD

Affiliated Hospital to Academy of Military Medical Sciences

Status

Unknown

Conditions

Colorectal Neoplasms

Treatments

Procedure: Endoscopic Barbed-clips Suturing

Study type

Interventional

Funder types

Other

Identifiers

NCT05045911

Endo-barbed clips suturing

Details and patient eligibility

About

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.

Full 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.

Enrollment

35 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.