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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novel Clip-Assisted Traction ESD/EFTR | Experimental | Patients will undergo ESD or EFTR using the "clip with line" traction method with the novel two-tooth clip. After initial circumferential mucosal incision, the two-tooth clip (with pre-tied line) will be anchored to the lesion. The endoscopist will apply continuous or intermittent traction via the line to optimize the submucosal view. After lesion retrieval, defects requiring closure will be managed using the same novel two-tooth clips in a purse-string configuration. |
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| Conventional ESD/EFTR | Active Comparator | Patients will undergo standard ESD or EFTR without the use of dedicated traction devices. The endoscopist may use transparent cap assistance and positional changes for exposure, which is current standard practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A Novel Two-Tooth Endoscopic Clip | Device | "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. |
| Measure | Description | Time Frame |
|---|---|---|
| Submucosal Dissection Efficiency | The rate of submucosal dissection (measured in mm²/min), calculated from the start of submucosal entry to the completion of lesion removal. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success Rate of Purse-String Closure | Percentage of cases where complete, circumferential mucosal/full-thickness defect closure is achieved using the novel two-tooth clip without conversion to alternative closure devices. | 24 hours |
| Incidence of Intraoperative Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Min, M.D., Ph.D. | Contact | +86-010-66947473 | minmin823@sina.com | |
| Yan Liu, M.D., Ph.D. | Contact | +86-010-66947473 | 13911798288@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yan Liu, M.D.,Ph.D. | Beijing 302 Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fifth Medical Center of Chinese PLA General Hospital | Recruiting | Beijing | 100071 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41802768 | Background | 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. | |
| 41388104 | Background | 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. |
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| ID | Term |
|---|---|
| D046152 | Gastrointestinal Stromal Tumors |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D013525 | Surgical Instruments |
| ID | Term |
|---|---|
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Clip | Device | Standard ESD or EFTR without the use of dedicated traction devices will be performed, then using the standard clips for closure. |
|
|
| 3 days |
| Defect Closure Time | Time taken to achieve complete purse-string closure of the post-resection defect. | 24 hours |
| Post-procedural Outcomes |
| 3 months |
| 40309063 | Background | 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. |
| 40834899 | Background | 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. |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |