NCT06350357

Conventional Clipping Versus Punching Closure

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Ningbo No. 1 Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• the Rate of Complete Closure

Interventions

Type	Name	Description
OTHER	punching closure	The hole clamping and the grooves hold the metal clips better
OTHER	Conventional clipping	Metal lip closure is one of the most commonly used closure methods

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-04-05
• Last updated: 2024-04-05

Locations

1 site across 1 country: China