Conventional Clipping Versus Punching Closure for Defect Closure After ESD:a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Endoscopic submucosal dissection (ESD) is an important minimally invasive treatment method for early digestive tract tumors, with a high cure rate, and it is widely used in clinical practice. And wound closure after ESD is a great challenge, which is closely related to postoperative perforation bleeding. Clip closure is one of the most commonly used closure methods. However, when the wound is large or when the wound is located more difficult to operate, conventional closure may lead to delayed perforation, and postoperative clips may be prone to early spontaneous shedding. The authors have recently reported a method that may be able to close larger and difficult wounds because the grooves can better fix the metal clips. The latest study suggests that this approach may be safe and effective, but the study has a small sample size and has no controls. Therefore, high-quality clinical study evidence related to punch closure is required in the strategy of defect closure after ESD, in order to better evaluate the feasibility and safety of this new endoscopic closure method.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 1\. Patients undergoing gastrointestinal ESD wound closure in the First Affiliated Hospital of Ningbo University from April 20, 2024 to December 31, 2025; 2. Age 18-75 years old; 3. Patients who voluntarily agreed to participate in this study and signed informed consent.

Locations
Other Locations
China
Ningbo first hospital
RECRUITING
Ningbo
Contact Information
Primary
Lei Xu
xulei22@163.com
+8613486659126
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 130
Treatments
Experimental: punching closure
punching closure for defect closure after ESD
Active_comparator: Conventional clipping
Conventional clipping for defect closure after ESD
Related Therapeutic Areas
Sponsors
Leads: Ningbo No. 1 Hospital

This content was sourced from clinicaltrials.gov