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RecruitingNCT06350357Updated Apr 5, 2024

Conventional Clipping Versus Punching Closure

An interventional study of punching closure and Conventional clipping in the Rate of Complete Closure, sponsored by Ningbo No. 1 Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-05.

Sponsored by Ningbo No. 1 Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Apr 2024; still recruiting 2 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • the Rate of Complete Closure
03

In context

Lead sponsor

Ningbo No. 1 Hospital is the lead sponsor of 56 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
130 participants (estimated)

Study arms

  • Experimental
    punching closure

    punching closure for defect closure after ESD

    Other: punching closure

  • Active comparator
    Conventional clipping

    Conventional clipping for defect closure after ESD

    Other: Conventional clipping

Interventions

  • Otherpunching closure

    The hole clamping and the grooves hold the metal clips better

  • OtherConventional clipping

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

06

What researchers measure

Primary outcomes

  1. Completely closed

    The wound is completely closed without dehiscence

    Time frame: 4 weeks

Secondary outcomes

  1. delayed hemorrhage

    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

    Time frame: 2 weeks and 4 weeks

07

Study locations

1 of 1 sites recruiting
  • Ningbo first hospital
    Ningbo, Zhejiang, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06350357
Lead sponsor
Ningbo No. 1 Hospital
Responsible party
Sponsor
First posted
Apr 5, 2024
Start date
Apr 1, 2024
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Apr 5, 2024

Study contacts

Lei Xu
Contact
xulei22@163.com
+8613486659126

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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