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Clinical Efficacy of Local Clip Closure After Left-Sided Colonic Endoscopic Submucosal Dissection: A Multicenter, Prospective, Non-Inferiority, Randomized Controlled Trial

Clinical Efficacy of Local Clip Closure After Left-Sided Colonic Endoscopic Submucosal Dissection: A Multicenter, Prospective, Non-Inferiority, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128644
Enrollment
Unknown
Registered
2026-07-23
Start date
2026-07-25
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early colorectal neoplasms located in the left-sided colon that are suitable for ESD resection

Interventions

Local Clip Closure Group:After ESD, the wound is thoroughly irrigated and suctioned to clearly expose the base. Metal clips are then applied selectively and targetedly to visible vascular stumps, acti
Full-Layer Closure Group:After ESD, metal clips are used to perform appositional suturing starting from the margins of the wound using the mucosa-submucosa clip closure method. The aim is to achieve c

Sponsors

the Second Affiliated Hospital of Army Medical University,PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Subjects must meet all of the following criteria: (1) Age >= 18 years and = 20 mm and <= 60 mm in size; (3) Lesion assessed as suitable for endoscopic submucosal dissection (ESD) by preoperative magnifying endoscopy or endoscopic ultrasound; (4) Patients who voluntarily agree to accept and comply with the trial protocol and have signed the informed consent form.

Exclusion criteria

Exclusion criteria: Subjects who meet any of the following criteria will be excluded from the study: (1) Thrombocytopenia, coagulation disorders, or bleeding tendency (INR > 1.5, APTT > 1.5 times the upper limit of normal, or platelet count = 1000 µm; (3) Locally recurrent lesions after prior endoscopic resection; (4) Familial adenomatous polyposis or inflammatory bowel disease; (5) Concurrent severe diseases; psychiatric disorders; or poor compliance (e.g., inability to participate in postoperative follow-up); (6) Pregnancy or lactation.

Design outcomes

Primary

MeasureTime frame
Incidence of delayed bleeding;Incidence of delayed perforation;

Secondary

MeasureTime frame
Duration of ESD procedure;Size of the resected specimen;Time required for wound closure/management);Total number of metal clips used;Postoperative abdominal pain score (VAS);Incidence of postoperative fever;Incidence of post-electrocoagulation syndrome, PECS;Length of postoperative hospital stay;Rate of emergency surgery or endoscopic intervention;Total medical cost related to the procedure;

Countries

China

Contacts

Public ContactNie Xubiao

the Second Affiliated Hospital of Army Medical University,PLA

398479956@qq.com+86 136 5833 4476

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026