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

NCT06973083 | Not Yet Recruiting DMC

• 1 other identifier: QLCR20230523
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• procedure time

  Procedure time is the time from the beginning of injection to the completion of dissection.

  Within 24 hours after the procedure.

Secondary Outcomes (18)

• dissection time

  Within 24 hours after the procedure.

• dissection speed

  Within 24 hours after the procedure.

• en bloc resection rate

  Within 24 hours after the procedure.

• R0 resection rate

  Within 24 hours after the procedure.

• perforation rate

  Within 24 hours after the procedure.

Study Arms (2)

FASTER-assisted ESD

EXPERIMENTAL

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

Procedure: FASTER-assisted ESD

Conventional ESD

ACTIVE COMPARATOR

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

Procedure: Conventional ESD

Interventions

FASTER-assisted ESD 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.

FASTER-assisted ESD

Conventional ESD PROCEDURE

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

Conventional ESD

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-85.
• Patients with pathologically verified colorectal neoplasms scheduled to undergo ESD.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Xiuli Zuo, Professor, MD, PhD

CONTACT

86+18560080066; zuoxiuli@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 15, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Locations

CN (1)