Comparing two methods for closing wounds after digestive tract tumor removal
Conventional Clipping Versus Punching Closure for Defect Closure After ESD：a Randomized Controlled Trial
This study is testing two different ways to close wounds after removing early digestive tract tumors to see which method works better and has fewer complications for patients aged 18-75.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Ningbo No. 1 Hospital Academic / other |
| Locations | 1 site (Ningbo, Zhejiang) |
| Trial ID | NCT06350357 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of two wound closure techniques, conventional clipping and punching closure, following endoscopic submucosal dissection (ESD) for early digestive tract tumors. The study aims to determine which method results in a higher rate of complete closure and fewer complications, such as postoperative bleeding. Patients aged 18-75 undergoing ESD at the First Affiliated Hospital of Ningbo University will be recruited for this trial, which will run from April 2024 to December 2025. The trial seeks to provide high-quality evidence to support the best practices in wound closure after ESD.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18-75 who are scheduled for gastrointestinal ESD at the First Affiliated Hospital of Ningbo University.
Not a fit: Patients under 18, those with severe chronic diseases, or those on anticoagulant therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved wound closure techniques, reducing complications and enhancing recovery for patients undergoing ESD.
How similar studies have performed: While similar approaches have been explored, this specific comparison of punching closure versus conventional clipping is novel and requires further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 1. Persons under the age of 18 2. Unwilling or unable to provide informed consent 3. Treatment or radiotherapy for malignant diseases, severe chronic heart or lung diseases, coronary or cerebrovascular events requiring hospitalization within the last 3 months 4.. Severe abdominal pain, bloating, nausea and other abdominal symptoms 5.. Patients with lifelong anticoagulant therapy or severe bleeding disorders, and patients who have recently taken anticoagulant or antiplatelet drugs 6. Pregnant or lactating 7. Patients with aggressive lesions and recurrent or residual tumors
Where this trial is running
Ningbo, Zhejiang
- Ningbo first hospital — Ningbo, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Lei Xu
- Email: xulei22@163.com
- Phone: +8613486659126
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.