An Endoscopic Barbed-clips Suturing for Colorectal ESD

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Neoplasms
• Intervention / Treatment: Procedure: Endoscopic Barbed-clips Suturing

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 Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yiliang Bi, Dr.; Phone Number: +8613240439961; Email: yiliangbi@163.com
• Study Contact Backup: Name: Pei Deng, Dr.

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • The First Medical Center of Chinese PLA General Hospital
      • Contact: Yan Liu; Phone Number: +8613911798288; Email: 13911798288@163.com
      • Principal Investigator: Yan Liu
    • Beijing, Beijing, China, 100071
      • Recruiting
      • The Fifth Medical Center of Chinese PLA General Hospital
      • Contact: Min Min, Dr.; Phone Number: +8613426165452; Email: minmin823@sina.com
      • Principal Investigator: Yan Liu, Pro.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Affiliated Hospital to Academy of Military Medical Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): September 20, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 20, 2021

Study Registration Dates

• First Submitted: August 17, 2021
• First Submitted That Met QC Criteria: September 14, 2021
• First Posted (Actual): September 16, 2021

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: Endo-barbed clips suturing

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No