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

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.

Study Overview

• Status: Recruiting
• Conditions: Early Gastric Cancer; Endoscopic Submucosal Dissection; Robot Surgery
• Intervention / Treatment: Procedure: FASTER-assisted ESD; Procedure: Conventional ESD

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiuli Zuo Professor, MD, PhD; Phone Number: 86+18560080066; Email: zuoxiuli@sdu.edu.cn

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Qilu Hospital of Shandong University
      • Contact: Xiuli Zuo Professor, MD, PhD; Phone Number: +86 18560080066; Email: zuoxiuli@sdu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FASTER-assisted ESD group; Patients in this group undergo ESD with the assistance of the FASTER system.	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.
Active Comparator: Conventional ESD group; Patients in this group undergo ESD following the clinically established pattern.	Procedure: Conventional ESD; The patients who are randomly assigned to the conventional ESD group will undergo the ESD following the clinically established pattern.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the number of muscular injuries	Muscular injury is described as visible damage to the muscularis propria.	Within 24 hours after the procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of muscular injury	Muscular injury is described as visible damage to the muscularis propria.	Within 24 hours after the procedure.
the frequency of intraoperative hemorrhage		Within 24 hours after the procedure.
the proportion of intraoperative hemorrhage ≥ grade 2	Intraoperative hemorrhage is divided into four grades: Grade 0 means no significant bleeding is observed during the procedure. Grade 1 means minimal bleeding, which could stop spontaneously or be easily controlled by cauterization with a dual knife. Grade 2 refers to minor hemorrhage that requires multiple cauterizations with a dual knife or hemostatic forceps. Grade 3 indicates massive hemorrhage that requires multiple cauterizations with hemostatic forceps.	Within 24 hours after the procedure.
hemostasis time	Hemostasis time referred to the time from the detection of submucosal bleeding until hemostasis was completed.	Within 24 hours after the procedure.
the frequency of supplemental injections	Supplemental injection refers to injections performed after the beginning of the dissection.	Within 24 hours after the procedure.
the supplemental injections time	The time of supplementary injection is from the insertion of the injection needle into the submucosal layer until the injection is completed and the needle is withdrawn.	Within 24 hours after the procedure.
procedure time	Procedure time is the time from the beginning of injection to the completion of dissection.	Within 24 hours after the procedure.
dissection time	Dissection time is the time from the beginning of dissection to the completion of dissection.	Within 24 hours after the procedure.
direct-vision dissection rate	Direct-vision dissection time is the time that the endoscopist can directly observe the tip of the dual knife and the submucosal layer at the same time. By dividing the direct-vision dissection time by the total dissection duration, the direct-vision dissection rate is calculated.	Within 24 hours after the procedure.
en bloc resection rate	En bloc dissection refers to the complete removal of the entire lesion in a single piece.	Within 24 hours after the procedure.
R0 resection rate	R0 resection is defined as en bloc resection with negative vertical and horizontal margins.	Within 24 hours after the procedure.

Collaborators and Investigators

• Sponsor: Shandong University

Study record dates

Study Major Dates

• Study Start (Estimated): December 30, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 21, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 21, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: SDU-QILU-G015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No