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

Official title

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

Overview

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.

Detailed description

Endoscopic Submucosal Dissection (ESD) and Endoscopic Full-Thickness Resection (EFTR) are established, minimally invasive techniques for the en-bloc resection of gastrointestinal stromal tumor (GIST). However, a persistent challenge, especially in difficult locations or large lesions, is the lack of sufficient counter-traction, which leads to prolonged procedure times, increased risk of intraoperative bleeding, and potential for incomplete resection due to poor visualization of the submucosal layer. Furthermore, managing large post resection defects or perforations requires reliable and technically feasible endoscopic suturing.

This study introduces a novel two-tooth clip. The device's geometry is hypothesized to provide a stronger, more stable grasp on the targeted tissue compared to standard single-tooth or non-toothed clips. The study will investigate two sequential applications of this clip within a single procedure:

The Traction Phase: A "clip with line" technique will be employed. The novel two-tooth clip will be anchored to the proximal edge of the lesion. A dental line, pre-tied to the clip, will be used by the endoscopist to apply adjustable counter-traction. This is intended to lift the lesion, tauten the submucosal fibers, and clearly expose the dissection plane, thereby simulating the principle of surgical counter-traction.

The Closure Phase: Following lesion resection, the novel two-tooth clip will be utilized to perform a continuous, circumferential closure of the mucosal defect or perforation. The study will assess the technical success rate, time required for complete closure, and the clip's ability to securely approximate tissue layers.

Interventions

• Device A Novel Two-Tooth Endoscopic Clip
  "Clip with line" traction method with the novel two-tooth clip will be applied in patients undergoing ESD or EFTR. After lesion retrieval, defects requiring closure will be managed using the same novel two-tooth clips.
• Device Clip
  Standard ESD or EFTR without the use of dedicated traction devices will be performed, then using the standard clips for closure.

Primary outcome measures

• Submucosal Dissection Efficiency [Time frame: 24 hours]

Secondary outcome measures (4)

• Technical Success Rate of Purse-String Closure [Time frame: 24 hours]
• Incidence of Intraoperative Adverse Events [Time frame: 3 days]
• Defect Closure Time [Time frame: 24 hours]
• Post-procedural Outcomes [Time frame: 3 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The Fifth Medical Center of Chinese PLA General Hospital — Beijing

Publications

• Zhang K, Hu S, Zhang X, Min M, Liu Y. The retained-bridge traction strategy: a novel solution for secure defect closure following duodenal endoscopic full-thickness resection. Endoscopy. 2026 Mar;58(S 01):E374-E375. doi: 10.1055/a-2804-6504. Epub 2026 Mar 9. No abstract available. PMID 41802768
• Hu S, Chu J, Qiao Y, Shen W, Tang A, Zhang H, Zhang X, Min M, Liu Y. A novel enhanced two-tooth clip for reliable defect closure endoscopically: An ex vivo comparative and in vivo feasibility study. Surg Endosc. 2026 Jan;40(1):864-874. doi: 10.1007/s00464-025-12450-5. Epub 2025 Dec 12. PMID 41388104
• Qiao Y, Hu S, Shen W, Tang A, Zhang X, Zhang H, Min M, Liu Y. Novel endoscopic gastric purse-string suture device for weight management in a porcine model (with video). Endosc Int Open. 2025 Apr 15;13:a25399167. doi: 10.1055/a-2539-9167. eCollection 2025. PMID 40309063
• Hu S, Qiao Y, Zhang X, Min M, Liu Y. Transrectal endoscopic resection of intraperitoneal gastrointestinal stromal tumor facilitated by incidental segmental absence of intestinal musculature. Endoscopy. 2025 Dec;57(S 01):E945-E946. doi: 10.1055/a-2665-7697. Epub 2025 Aug 20. No abstract available. PMID 40834899

Identifiers

NCT: NCT07581977 · TTC-GIST

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗