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Not yet recruiting NCT06973083

Efficacy and Safety of Robot-assisted Endoscopic Submucosal Dissection for Colorectal Neoplasm

No phase Interventional Robot Surgery Endoscopic Submucosal Dissection (ESD) Colorectal Neoplasms

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: Robot Surgery, Endoscopic Submucosal Dissection (ESD), Colorectal Neoplasms. Basic parameters: 18 years — 85 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

Efficacy and Safety of Robot-assisted Endoscopic Submucosal Dissection for Colorectal Neoplasm: A Randomized Controlled Trial.

Overview

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.

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

  • procedure time [Time frame: Within 24 hours after the procedure.]
Secondary outcome measures (12)
  • dissection time [Time frame: Within 24 hours after the procedure.]
  • dissection speed [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.]
  • perforation rate [Time frame: Within 24 hours after the procedure.]
  • postoperative hemorrhage rate [Time frame: Within 24 hours after the procedure.]
  • intraoperative hemorrhage rate [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.]
  • muscular injury rate [Time frame: Within 24 hours after the procedure.]
  • direct-vision dissection rate [Time frame: Within 24 hours after the procedure.]
  • postoperative pain score [Time frame: 3 days after the procedure.]

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.

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: NCT06973083 · QLCR20230523

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗