An Endoscopic Barbed-clips Suturing for Colorectal ESD

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05045911
• Other study ID #: Endo-barbed clips suturing
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2021
• Est. completion date: December 20, 2021

Study information

• Verified date: September 2021
• Source: Affiliated Hospital to Academy of Military Medical Sciences
• Contact: Yiliang Bi, Dr.
• Phone: +8613240439961
• Email: yiliangbi[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: December 20, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Procedure:
• Endoscopic Barbed-clips Suturing
Endoscopic Barbed-clips Suturing

Locations

Country	Name	City	State
China	The Fifth Medical Center of Chinese PLA General Hospital	Beijing	Beijing
China	The First Medical Center of Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital to Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The technical success rate	Rate of completely closure of the ESD defect	1 day
Secondary	Endoscopic barbed-clips suturing closure time	The time required to close the defect using endoscopic barbed-clips suturing	1 day
Secondary	Rate of patients reported with bleeding/perforation post-ESD procedure	Conduct follow-ups for risk of bleeding and perforation after closure	7 days
Secondary	Clips used post-ESD	Record number of clips needed to close lesion	7 days