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

NCT ID: NCT06973083

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-12-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

FASTER-assisted ESD

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

Group Type: EXPERIMENTAL

FASTER-assisted ESD

Intervention Type: PROCEDURE

The patients who are randomly assigned to the FASTER-assisted ESD group will undergo the ESD procedure with the assistance of the FASTER system.

Conventional ESD

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

Group Type: ACTIVE_COMPARATOR

Conventional ESD

Intervention Type: PROCEDURE

The patients who are randomly assigned to the conventional ESD group will undergo the ESD following the clinically established pattern.

Interventions

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.

Intervention Type: PROCEDURE

Conventional ESD

The patients who are randomly assigned to the conventional ESD group will undergo the ESD following the clinically established pattern.

Intervention Type: 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Xiuli Zuo

Professor, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Qilu Hospital of Shandong University

Jinan, Shandong, China

Countries

China

Central Contacts

Xiuli Zuo, Professor, MD, PhD

Role: CONTACT

zuoxiuli@sdu.edu.cn

86+18560080066

Facility Contacts

Xiuli Zuo, Professor, MD, PhD

Role: primary

zuoxiuli@sdu.edu.cn

+86 18560080066

Other Identifiers

QLCR20230523

Identifier Type: -

Identifier Source: org_study_id