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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Neoplasms; Robot Surgery; Endoscopic Submucosal Dissection (ESD)
• Intervention / Treatment: Procedure: FASTER-assisted ESD; Procedure: Conventional ESD

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiuli Zuo, Professor, MD, PhD; Phone Number: 86+18560080066; Email: zuoxiuli@sdu.edu.cn

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital of Shandong University
      • Contact: Xiuli Zuo, Professor, MD, PhD; Phone Number: +86 18560080066; Email: zuoxiuli@sdu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FASTER-assisted ESD; Patients in this group undergo ESD with the assistance of the FASTER system.	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.
Active Comparator: Conventional ESD; Patients in this group undergo ESD following the clinically established pattern.	Procedure: Conventional ESD; The patients who are randomly assigned to the conventional ESD group will undergo the ESD following the clinically established pattern.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
procedure time	Procedure time is the time from the beginning of injection to the completion of dissection.	Within 24 hours after the procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the proportion of intraoperative hemorrhage ≥ grade 2	Intraoperative hemorrhage is divided into four grades: Grade 0 means no significant bleeding is observed during the procedure. Grade 1 means minimal bleeding, which could stop spontaneously or be easily controlled by cauterization with a dual knife. Grade 2 refers to minor hemorrhage that requires multiple cauterizations with a dual knife or hemostatic forceps. Grade 3 indicates massive hemorrhage that requires multiple cauterizations with hemostatic forceps.	Within 24 hours after the procedure.
hemostasis time	Hemostasis time referred to the time from the detection of submucosal bleeding until hemostasis was completed.	Within 24 hours after the procedure.
the frequency of supplemental injections	Supplemental injection refers to injections performed after the beginning of the dissection.	Within 24 hours after the procedure.
the supplemental injections time	The time of supplementary injection is from the insertion of the injection needle into the submucosal layer until the injection is completed and the needle is withdrawn.	Within 24 hours after the procedure.
dissection time	Dissection time is the time from the beginning of dissection to the completion of dissection.	Within 24 hours after the procedure.
direct-vision dissection rate	Direct-vision dissection time is the time that the endoscopist can directly observe the tip of the dual knife and the submucosal layer at the same time. By dividing the direct-vision dissection time by the total dissection duration, the direct-vision dissection rate is calculated.	Within 24 hours after the procedure.
en bloc resection rate	En bloc dissection refers to the complete removal of the entire lesion in a single piece.	Within 24 hours after the procedure.
R0 resection rate	R0 resection is defined as en bloc resection with negative vertical and horizontal margins.	Within 24 hours after the procedure.
dissection speed	Dissection speed is defined as the lesion area divided by the dissection time.	Within 24 hours after the procedure.
perforation rate	Perforation were defined as: endoscopic visualization of mural transection during ESD, or postoperative clinical signs combined with radiologically confirmed pneumoperitoneum.	Within 24 hours after the procedure.
postoperative hemorrhage rate	Post-ESD hemorrhage was strictly defined as meeting ≥1 of: hematemesis or melena with dizziness, hemoglobin decline >20 g/L, SBP drop >20 mmHg or HR elevation >20 bpm, presence of bloody fluid in nasogastric tube drainage, or active bleeding confirmed by repeat endoscopy.	Within 24 hours after the procedure.
intraoperative hemorrhage rate		Within 24 hours after the procedure.
muscular injury rate	Muscular injury is described as visible damage to the muscularis propria.	Within 24 hours after the procedure.
postoperative pain score	Postoperative pain score was assessed via the 11-point Numerical Rating Scale (NRS: 0=no pain, 10=worst imaginable pain). Patients independently rated their pain intensity on postoperative day 3, with scores categorized as mild (1-3), moderate (4-6), or severe (7-10).*	3 days after the procedure.
Volume of injection fluid used in supplemental injections		Within 24 hours after the procedure.
the frequency of intraoperative patient positioning changes		Within 24 hours after the procedure.
time required for patient positioning changes		Within 24 hours after the procedure.
NASA-TLX scale scores		Within 24 hours after the procedure.

Collaborators and Investigators

• Sponsor: Shandong University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: May 7, 2025
• First Submitted That Met QC Criteria: May 7, 2025
• First Posted (Actual): May 15, 2025

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 16, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Neoplasms; Colorectal Neoplasms
• Other Study ID Numbers: QLCR20230523

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No