A Novel Two-Tooth Clip for ESD and EFTR of GIST

Summary

This study is designed to evaluate the efficacy and safety of a novel two-tooth endoscopic clip, utilized in a "clip with line" traction configuration, during endoscopic resection procedures (ESD and EFTR) of GIST. The novel clip's dual-tooth design is intended to provide a more secure anchor on the lesion, enabling effective counter-traction when combined with a line. The primary aim is to determine if this method improves submucosal dissection efficiency compared to conventional ESD. A secondary aim is to evaluate the performance of the same clip system for full-thickness or mucosal defect closure.

Eligibility

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.

Conditions2

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