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

Not Applicable

Recruiting

• Conditions: Early Gastric Cancer; Endoscopic Submucosal Dissection; Robot Surgery

• Registration Number: NCT06748352
• Lead Sponsor: Shandong University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-21
• Last Update Submitted: 2024-12-21
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Study Start: 2024-12-30
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
the number of muscular injuries	Within 24 hours after the procedure.	Muscular injury is described as visible damage to the muscularis propria.

Secondary Outcome Measures

Name	Time	Method
dissection time	Within 24 hours after the procedure.	Dissection time is the time from the beginning of dissection to the completion of dissection.
the incidence of muscular injury	Within 24 hours after the procedure.	Muscular injury is described as visible damage to the muscularis propria.
the frequency of intraoperative hemorrhage	Within 24 hours after the procedure.
the proportion of intraoperative hemorrhage ≥ grade 2	Within 24 hours after the procedure.	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.
hemostasis time	Within 24 hours after the procedure.	Hemostasis time referred to the time from the detection of submucosal bleeding until hemostasis was completed.
the frequency of supplemental injections	Within 24 hours after the procedure.	Supplemental injection refers to injections performed after the beginning of the dissection.
the supplemental injections time	Within 24 hours after the procedure.	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.
procedure time	Within 24 hours after the procedure.	Procedure time is the time from the beginning of injection to the completion of dissection.
direct-vision dissection rate	Within 24 hours after the procedure.	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.
en bloc resection rate	Within 24 hours after the procedure.	En bloc dissection refers to the complete removal of the entire lesion in a single piece.
R0 resection rate	Within 24 hours after the procedure.	R0 resection is defined as en bloc resection with negative vertical and horizontal margins.

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China