Two-tooth endoscopic clip to help remove and close stomach GISTs

Efficacy and Safety of a Novel Two-Tooth Clip-Assisted ESD and EFTR of GIST: A Single-Center, Prospective, Open-Label, Randomized Controlled Study

Doctors will try a new two-tooth endoscopic clip used with a clip-and-line traction method during ESD and EFTR to see if it makes removing and closing gastric GISTs (2–5 cm) faster and safer for adults.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Affiliated Hospital to Academy of Military Medical Sciences (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07581977 on ClinicalTrials.gov

What this trial studies

This is a prospective randomized trial comparing a novel two-tooth endoscopic clip used in a clip-with-line traction technique versus conventional ESD methods for adults with gastric GISTs 2–5 cm. In the procedure the clip will first be anchored to the lesion and a dental line used to provide counter-traction to expose the submucosal dissection plane, and after resection the same clip system will be used for continuous circumferential defect closure. Primary outcomes include measures of submucosal dissection efficiency (procedure time and en-bloc resection completeness) and safety, while secondary outcomes focus on closure performance for full-thickness or mucosal defects. All procedures are performed by experienced endoscopists following standard inclusion and exclusion criteria.

Who should consider this trial

Good fit: Adults 18–85 years old with gastric GISTs 2–5 cm who are appropriate candidates for endoscopic resection and can safely pause/bridge anticoagulation are the intended participants.

Not a fit: Patients with clear deep submucosal invasion or distant metastases, severe coagulopathy or organ failure, pregnancy or lactation, or prior significant fibrosis at the lesion site are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, the device could shorten procedure time, improve visualization for complete resection, reduce bleeding and perforation risk, and simplify defect closure.

How similar studies have performed: Clip-with-line traction methods and endoscopic closure techniques have demonstrated benefit in prior work, but the two-tooth clip geometry is a novel device with limited prior clinical data.

Eligibility criteria

Inclusion Criteria:

Age ≥ 18 and ≤ 85 years. Patients diagnosed with gastric gastrointestinal lesions clinically indicated for ESD or EFTR.

Lesion size between 2 cm and 5 cm in diameter. Willing and able to provide written informed consent.

Exclusion Criteria:

Lesions with clear evidence of deep submucosal invasion or distant metastasis precluding curative endoscopic resection.

Severe coagulation dysfunction (international normalized ratio \>2.0, platelet count \<50,000/µL) or ongoing use of dual antiplatelet therapy/anticoagulants that cannot be appropriately bridged or discontinued per guidelines.

Severe organ failure (cardiac, renal, hepatic, or respiratory) rendering the patient unsuitable for prolonged sedation or general anesthesia.

Pregnancy or lactation. Prior surgical or endoscopic intervention at the target lesion site that results in significant fibrosis.

Where this trial is running

Beijing

• The Fifth Medical Center of Chinese PLA General Hospital — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Yan Liu, M.D.,Ph.D. — Beijing 302 Hospital
• Study coordinator: Min Min, M.D., Ph.D.

Conditions GIST - Gastrointestinal Stromal Tumor; GIST, ESD, EFTR, two-tooth clips