Safety and Efficacy of Traction Robot-assisted Endoscopic Submucosal Dissection for Early Gastric Cancer

Last updated: December 21, 2024
Sponsor: Shandong University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stomach Cancer

Gastric Cancer

Digestive System Neoplasms

Treatment

FASTER-assisted ESD

Conventional ESD

Clinical Study ID

NCT06748352
SDU-QILU-G015
  • Ages 18-80
  • All Genders

Study Summary

The goal of this clinical trial is to investigate whether the flexible auxiliary single-arm transluminal endoscopic robot (FASTER) system can improve the safety of the endoscopic submucosal dissection (ESD). It will also evaluate the efficacy of the system, such as whether it could reduce the procedure time and so on. The main questions it aims to answer are:

Does the use of the FASTER system reduce the number of muscular injuries, improving the safety of the ESD procedure? Does the use of the FASTER system reduce the procedure and dissection time, improving the efficacy of the ESD procedure? Researchers will compare FASTER-assisted ESD and conventional ESD to evaluate the safety and efficacy of the FASTER system.

Participants will:

Be randomly assigned to the group with ESD using the traditional procedure or to the group with ESD assisted by the FASTER system.

Keep a diary of their symptoms after the procedure. ESD has gained widespread acceptance as the standard method for treating early-stage gastrointestinal cancers. Adequate exposure of the submucosa layer through effective tissue traction is vital for the safe and effective performance of ESD. The FASTER system is designed to overcome this technical difficulty.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients aged 18-80.

  • Patients with pathologically verified high-grade intraepithelial neoplasia (HGIN) orintramucosal carcinoma of the stomach.

Exclusion

Exclusion Criteria:

  • Patients have lesions with confirmed or potential deep submucosal invasion or lymphnode metastasis.

  • Patients with severe underlying diseases precluding endotracheal intubation, generalanesthesia, or surgery.

  • Patients have a history of gastric malignancy with previous radiotherapy oroperative treatment leading to changes in gastric structure.

  • Patients have lesions with local recurrence after endoscopic resection.

  • Patients unable to obtain informed consent.

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: FASTER-assisted ESD
Phase:
Study Start date:
December 30, 2024
Estimated Completion Date:
March 01, 2025

Connect with a study center

  • Qilu Hospital of Shandong University

    Jinan, Shandong 250012
    China

    Active - Recruiting

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