Conventional Clipping Versus Punching Closure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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the Rate of Complete Closure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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punching closure

punching closure for defect closure after ESD

Group Type EXPERIMENTAL

punching closure

Intervention Type OTHER

The hole clamping and the grooves hold the metal clips better

Conventional clipping

Conventional clipping for defect closure after ESD

Group Type ACTIVE_COMPARATOR

Conventional clipping

Intervention Type OTHER

Metal lip closure is one of the most commonly used closure methods

Interventions

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punching closure

The hole clamping and the grooves hold the metal clips better

Intervention Type OTHER

Conventional clipping

Metal lip closure is one of the most commonly used closure methods

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No