An Endoscopic Barbed-clips Suturing for Colorectal ESD
Primary Purpose
Colorectal Neoplasms
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Endoscopic Barbed-clips Suturing
Sponsored by

About this trial
This is an interventional treatment trial for Colorectal Neoplasms
Eligibility Criteria
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.
Sites / Locations
- The Fifth Medical Center of Chinese PLA General HospitalRecruiting
- The First Medical Center of Chinese PLA General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Endoscopic Barbed-clips Suturing
Arm Description
Patients will be closed the mucosal defect after colorectal ESD using Endoscopic Barbed-clips Suturing.
Outcomes
Primary Outcome Measures
The technical success rate
Rate of completely closure of the ESD defect
Secondary Outcome Measures
Endoscopic barbed-clips suturing closure time
The time required to close the defect using endoscopic barbed-clips suturing
Rate of patients reported with bleeding/perforation post-ESD procedure
Conduct follow-ups for risk of bleeding and perforation after closure
Clips used post-ESD
Record number of clips needed to close lesion
Full Information
NCT ID
NCT05045911
First Posted
August 17, 2021
Last Updated
September 14, 2021
Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05045911
Brief Title
An Endoscopic Barbed-clips Suturing for Colorectal ESD
Official Title
A Novel Endoscopic Barbed-clips Suturing for Mucosal Defect Closure After Endoscopic Submucosal Dissection of Colon
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 20, 2021 (Anticipated)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
December 20, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Endoscopic Barbed-clips Suturing
Arm Type
Experimental
Arm Description
Patients will be closed the mucosal defect after colorectal ESD using Endoscopic Barbed-clips Suturing.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Barbed-clips Suturing
Intervention Description
Endoscopic Barbed-clips Suturing
Primary Outcome Measure Information:
Title
The technical success rate
Description
Rate of completely closure of the ESD defect
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Endoscopic barbed-clips suturing closure time
Description
The time required to close the defect using endoscopic barbed-clips suturing
Time Frame
1 day
Title
Rate of patients reported with bleeding/perforation post-ESD procedure
Description
Conduct follow-ups for risk of bleeding and perforation after closure
Time Frame
7 days
Title
Clips used post-ESD
Description
Record number of clips needed to close lesion
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yiliang Bi, Dr.
Phone
+8613240439961
Email
yiliangbi@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pei Deng, Dr.
Facility Information:
Facility Name
The Fifth Medical Center of Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Min, Dr.
Phone
+8613426165452
Email
minmin823@sina.com
First Name & Middle Initial & Last Name & Degree
Yan Liu, Pro.
Facility Name
The First Medical Center of Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Liu
Phone
+8613911798288
Email
13911798288@163.com
First Name & Middle Initial & Last Name & Degree
Yan Liu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Endoscopic Barbed-clips Suturing for Colorectal ESD
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