Clinical trial NCT06973083: Efficacy and Safety of Robot-assisted Endoscopic Submucosal Dissection for Colorectal Neoplasm
Official title: Efficacy and Safety of Robot-assisted Endoscopic Submucosal Dissection for Colorectal Neoplasm: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Robot Surgery
Endoscopic Submucosal Dissection (ESD)
Colorectal Neoplasms
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to investigate the role of the flexible auxiliary single-arm transluminal endoscopic robot (FASTER) system in colorectal endoscopic submucosal dissection (ESD) and to validate its superiority over conventional ESD in terms of reducing procedural difficulty, shortening procedure time, and enhancing procedural safety.

The main questions it aims to answer are:

Does the use of the FASTER system improve the dissection speed of the ESD procedure? Does the use of the FASTER system reduce the procedure and dissection time, improving the efficacy of the ESD procedure? Does the use of the FASTER system reduce the rate of perforation and hemorrhage, improving the safety 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. However, ESD is a technically demanding and intricate procedure that requires advanced proficiency of operators, with a heightened risk of complications such as hemorrhage and perforation. The inherent challenges of the colorectal ESD are further amplified by the thin mucosa, highly tortuous and flexible lumen, and occasional obstruction of lesions by mucosal folds, all of which collectively elevate both the procedural difficulty and the probability of postoperative complications. 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 18-85.
* Patients with pathologically verified colorectal neoplasms scheduled to undergo ESD.

Exclusion Criteria:

* Patients have lesions with confirmed or potential deep submucosal invasion or lymph node metastasis or other conditions that are not suitable for endoscopic therapy.
* Patients with severe underlying diseases precluding endotracheal intubation, general anesthesia, or surgery.
* Patients have a history of colorectal malignancy with previous radiotherapy or operative treatment leading to changes in colorectal structure.
* Patients have lesions with local recurrence after endoscopic resection.
* Patients unable to obtain informed consent.

Primary outcomes:
measure: procedure time
timeFrame: Within 24 hours after the procedure.
Secondary outcomes:
measure: dissection time
timeFrame: Within 24 hours after the procedure.
measure: dissection speed
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.
measure: perforation rate
timeFrame: Within 24 hours after the procedure.
measure: postoperative hemorrhage rate
timeFrame: Within 24 hours after the procedure.
measure: intraoperative hemorrhage rate
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: muscular injury rate
timeFrame: Within 24 hours after the procedure.
measure: direct-vision dissection rate
timeFrame: Within 24 hours after the procedure.
measure: postoperative pain score
timeFrame: 3 days 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: Volume of injection fluid used in supplemental injections
timeFrame: Within 24 hours after the procedure.
measure: the frequency of intraoperative patient positioning changes
timeFrame: Within 24 hours after the procedure.
measure: time required for patient positioning changes
timeFrame: Within 24 hours after the procedure.
measure: NASA-TLX scale scores
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: