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RECRUITINGINTERVENTIONAL

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

Safety and Efficacy of Traction Robot-assisted Endoscopic Submucosal Dissection for Early Gastric Cancer: a Pilot Randomized Controlled Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Patients aged 18-80. - Patients with pathologically verified high-grade intraepithelial neoplasia (HGIN) or intramucosal carcinoma of the stomach. Who Should NOT Join This Trial: - Patients have lesions with confirmed or potential deep submucosal invasion or lymph node metastasis. - Patients with severe underlying diseases precluding endotracheal intubation, general anesthesia, or surgery. - Patients have a history of gastric malignancy with previous radiotherapy or operative treatment leading to changes in gastric structure. - Patients have lesions with local recurrence after endoscopic resection. - Patients unable to obtain willing to sign a consent form. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Patients aged 18-80. * Patients with pathologically verified high-grade intraepithelial neoplasia (HGIN) or intramucosal carcinoma of the stomach. Exclusion Criteria: * Patients have lesions with confirmed or potential deep submucosal invasion or lymph node metastasis. * Patients with severe underlying diseases precluding endotracheal intubation, general anesthesia, or surgery. * Patients have a history of gastric malignancy with previous radiotherapy or operative treatment leading to changes in gastric structure. * Patients have lesions with local recurrence after endoscopic resection. * Patients unable to obtain informed consent.

Treatments Being Tested

PROCEDURE

FASTER-assisted ESD

The patients who are randomly assigned to the FASTER-assisted ESD group will undergo the ESD procedure with the assistance of the FASTER system.

PROCEDURE

Conventional ESD

The patients who are randomly assigned to the conventional ESD group will undergo the ESD following the clinically established pattern.

Locations (1)

Qilu Hospital of Shandong University
Jinan, Shandong, China