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

NCT06748352 | Recruiting DMC

• 1 other identifier: SDU-QILU-G015
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Early Gastric Cancer; Endoscopic Submucosal Dissection; Robot Surgery

Outcome Measures

Primary Outcomes (1)

• the number of muscular injuries

  Muscular injury is described as visible damage to the muscularis propria.

  Within 24 hours after the procedure.

Secondary Outcomes (11)

• the incidence of muscular injury

  Within 24 hours after the procedure.

• the frequency of intraoperative hemorrhage

  Within 24 hours after the procedure.

• the proportion of intraoperative hemorrhage ≥ grade 2

  Within 24 hours after the procedure.

• hemostasis time

  Within 24 hours after the procedure.

• the frequency of supplemental injections

  Within 24 hours after the procedure.

Study Arms (2)

FASTER-assisted ESD group

EXPERIMENTAL

Patients in this group undergo ESD with the assistance of the FASTER system.

Procedure: FASTER-assisted ESD

Conventional ESD group

ACTIVE COMPARATOR

Patients in this group undergo ESD following the clinically established pattern.

Procedure: Conventional ESD

Interventions

FASTER-assisted ESD PROCEDURE

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

FASTER-assisted ESD group

Conventional ESD PROCEDURE

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

Conventional ESD group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-80.
• Patients with pathologically verified high-grade intraepithelial neoplasia (HGIN) or intramucosal carcinoma of the stomach.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Xiuli Zuo Professor, MD, PhD

CONTACT

86+18560080066; zuoxiuli@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 27, 2024
• Study Start: December 30, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

CN (1)