Clinical trial NCT06748352: Safety and Efficacy of Traction Robot-assisted Endoscopic Submucosal Dissection for Early Gastric Cancer
Official title: Safety and Efficacy of Traction Robot-assisted Endoscopic Submucosal Dissection for Early Gastric Cancer: a Pilot Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Early Gastric Cancer
Endoscopic Submucosal Dissection
Robot Surgery
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: the number of muscular injuries
timeFrame: Within 24 hours after the procedure.
Secondary outcomes:
measure: the incidence of muscular injury
timeFrame: Within 24 hours after the procedure.
measure: the frequency of intraoperative hemorrhage
timeFrame: Within 24 hours after the procedure.
measure: the proportion of intraoperative hemorrhage ≥ grade 2
timeFrame: Within 24 hours after the procedure.
measure: hemostasis time
timeFrame: Within 24 hours after the procedure.
measure: the frequency of supplemental injections
timeFrame: Within 24 hours after the procedure.
measure: the supplemental injections time
timeFrame: Within 24 hours after the procedure.
measure: procedure time
timeFrame: Within 24 hours after the procedure.
measure: dissection time
timeFrame: Within 24 hours after the procedure.
measure: direct-vision dissection rate
timeFrame: Within 24 hours after the procedure.
measure: en bloc resection rate
timeFrame: Within 24 hours after the procedure.
measure: R0 resection rate
timeFrame: Within 24 hours after the procedure.
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
References: