Conventional Clipping Versus Punching Closure

Not Applicable

Recruiting

• Conditions: the Rate of Complete Closure
• Interventions: Other: punching closure; Other: Conventional clipping

• Registration Number: NCT06350357
• Lead Sponsor: Ningbo No. 1 Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study Start: 2024-04-01
• Study First Submitted: 2024-04-01
• Study First Submitted QC: 2024-04-01
• Last Update Submitted: 2024-04-01
• Study First Posted: 2024-04-05
• Last Update Posted: 2024-04-05
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
punching closure	punching closure	punching closure for defect closure after ESD
Conventional clipping	Conventional clipping	Conventional clipping for defect closure after ESD

Primary Outcome Measures

Name	Time	Method
Completely closed	4 weeks	The wound is completely closed without dehiscence

Secondary Outcome Measures

Name	Time	Method
delayed hemorrhage	2 weeks and 4 weeks	Any symptoms of gastrointestinal bleeding (e. g. hematochezia) occurred within 30 days after polypectomy and were classified as mild or severe according on the severity of the bleeding

Trial Locations

Locations (1)

Ningbo first hospital; 🇨🇳 Ningbo, Zhejiang, China