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Recruiting NCT06748352

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

No phase Interventional Early Gastric Cancer Endoscopic Submucosal Dissection Robot Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FASTER-assisted ESD, Conventional ESD.
Who it may be relevant to
Registry conditions: Early Gastric Cancer, Endoscopic Submucosal Dissection, Robot Surgery. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • the number of muscular injuries [Time frame: Within 24 hours after the procedure.]
Secondary outcome measures (11)
  • the incidence of muscular injury [Time frame: Within 24 hours after the procedure.]
  • the frequency of intraoperative hemorrhage [Time frame: Within 24 hours after the procedure.]
  • the proportion of intraoperative hemorrhage ≥ grade 2 [Time frame: Within 24 hours after the procedure.]
  • hemostasis time [Time frame: Within 24 hours after the procedure.]
  • the frequency of supplemental injections [Time frame: Within 24 hours after the procedure.]
  • the supplemental injections time [Time frame: Within 24 hours after the procedure.]
  • procedure time [Time frame: Within 24 hours after the procedure.]
  • dissection time [Time frame: Within 24 hours after the procedure.]
  • direct-vision dissection rate [Time frame: Within 24 hours after the procedure.]
  • en bloc resection rate [Time frame: Within 24 hours after the procedure.]
  • R0 resection rate [Time frame: Within 24 hours after the procedure.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Qilu Hospital of Shandong University — Jinan

Identifiers

NCT: NCT06748352 · SDU-QILU-G015

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗