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

Shandong University

Status: Not yet enrolling

Conditions: Endoscopic Submucosal Dissection (ESD); Robot Surgery; Colorectal Neoplasms

Treatments: Procedure: Conventional ESD; Procedure: FASTER-assisted ESD

Study type: Interventional

Funder types: Other

Identifiers

NCT06973083

QLCR20230523

Details and patient eligibility

About

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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104 participants in 2 patient groups

FASTER-assisted ESD

Experimental group

Description:

Patients in this group undergo ESD with the assistance of the FASTER system.

Treatment:

Procedure: FASTER-assisted ESD

Conventional ESD

Active Comparator group

Description:

Patients in this group undergo ESD following the clinically established pattern.

Treatment:

Procedure: Conventional ESD