Effect of Simplified Robot (FASTER) Assisted Versus Conventional Endoscopic Submucosal Dissection (ESD) for Colorectal Lesions

Effect of Simplified Robot (FASTER) Assisted Versus Conventional Endoscopic Submucosal Dissection (ESD) for Colorectal Lesions: A Prospective, Randomized, Controlled Trial

This study aims to compare the outcomes of Simplified Robot (FASTER) assisted Endoscopic Submucosal Dissection (ESD) with conventional ESD in the treatment of colorectal lesions. Using a prospective, single-center, randomized controlled design, the investigators will systematically evaluate differences between the two approaches in terms of total procedure time, mucosal dissection time and speed, resection quality (R0 resection rate and en bloc resection rate), incidence of complications (bleeding, perforation, muscularis injury), and the flexibility and clinical feasibility of robotic operation. The clinical significance of this study lies in assessing the value of robotic assistance in colorectal ESD, optimizing intraoperative workflow, reducing complication risks, improving patient outcomes and procedural efficiency, and providing evidence to support individualized therapeutic strategies in clinical practice.This study aims to compare the outcomes of Simplified Robot (FASTER) assisted Endoscopic Submucosal Dissection (ESD) with conventional ESD in the treatment of colorectal lesions. Using a prospective, single-center, randomized controlled design, the investigators will systematically evaluate differences between the two approaches in terms of total procedure time, mucosal dissection time and speed, resection quality (R0 resection rate and en bloc resection rate), incidence of complications (bleeding, perforation, muscularis injury), and the flexibility and clinical feasibility of robotic operation. The clinical significance of this study lies in assessing the value of robotic assistance in colorectal ESD, optimizing intraoperative workflow, reducing complication risks, improving patient outcomes and procedural efficiency, and providing evidence to support individualized therapeutic strategies in clinical practice.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Lesions; Endoscopic Submucosal Dissection (ESD); FASTER Robot
• Intervention / Treatment: Other: FASTER robot-assisted ESD group; Other: Conventional ESD group

Detailed Description

This study is a prospective, single-center, randomized controlled trial enrolling patients scheduled to undergo endoscopic submucosal dissection (ESD) for colorectal lesions. Eligible subjects will be screened according to predefined inclusion and exclusion criteria and, after providing written informed consent, randomized 1:1 to the experimental group (FASTER robot-assisted ESD) or the control group (conventional ESD). All participants will undergo standardized ESD performed by experienced endoscopists.

In the experimental group, after a circumferential incision is completed, the FASTER robotic arm will be used; its end-effector grasper will apply multidirectional traction to the lesion margins to optimize the submucosal field before completing the dissection. The control group will undergo mucosal-submucosal dissection using conventional ESD techniques.

Postoperatively, all participants will receive routine acid-suppression therapy and begin a warm, cool liquid diet 6 hours after the procedure. If no intolerance occurs within 24 hours, the diet will be advanced stepwise to semi-liquid and then soft foods until discharge.

During treatment, the following parameters will be recorded and evaluated: total procedure time, mucosal dissection time and dissection speed, resection quality (R0 resection rate and en-bloc resection rate), complication rates (bleeding, perforation, muscularis propria injury), procedural stability, and robotic maneuverability. All participants will be followed during the postoperative hospitalization period, with collection of clinical status, laboratory results, and device-related information.

The study team will conduct statistical analyses to compare the two approaches in terms of efficacy and safety, evaluate their clinical applicability, and provide scientific evidence to support optimization of colorectal ESD workflows and the broader adoption of robot-assisted technology.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: xiaobing cui; Phone Number: 13631312723; Email: xbing119@163.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Age between 18 and 80 years.
2. Patients with colorectal lesions scheduled to undergo endoscopic submucosal dissection (ESD)
3. Lesion characteristics meeting any of the following criteria: (1) Lesions unsuitable for en bloc resection using snare-based EMR, including non-granular type laterally spreading tumors (LST-NG), especially pseudo-depressed subtype (PD); lesions with type VI pit pattern (VI-type glandular opening configuration); carcinomas with superficial submucosal invasion (T1-SM); large depressed-type tumors; large protruding lesions suspected of malignancy, including nodular mixed-type granular LSTs (LST-G); other lesions unsuitable for en bloc resection using snare-based EMR; (2) Lesions with special background conditions, including mucosal tumors with submucosal fibrosis (caused by prior biopsy or mucosal prolapse due to peristalsis); sporadic tumors arising in the context of chronic inflammation (e.g., ulcerative colitis); local residual or recurrent early carcinoma following prior endoscopic resection;
4. Willingness to participate in the study and provision of written informed consent.

Exclusion Criteria:

1. Suspected deep submucosal invasive carcinoma based on endoscopic features；
2. Lesions presenting with non-lifting signs, suggesting deep submucosal invasive carcinoma or tumors with severe submucosal fibrosis;
3. Lesions extending to the appendiceal orifice, colonic diverticulum, or ileocecal valve; (4) Pregnant women or women who may be pregnant; lactating women;
4. Pregnant women or women who may be pregnant; lactating women;
5. Patients with coagulation disorders;
6. Patients considered ineligible for specific reasons;
7. Patients with contraindications to anesthesia and/or colonoscopy. -

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FASTER robot-assisted ESD group; FASTER robot-assisted ESD group - Patients undergo ESD with the FASTER robotic arm attached to the endoscope tip, with robotic grasping to assist submucosal dissection.	Other: FASTER robot-assisted ESD group; In the experimental group, the FASTER robotic arm will be attached to the tip of the endoscope at the beginning of the procedure. ESD will then be performed according to the standard steps of conventional ESD: (1) lesion marking; (2) submucosal injection with normal saline mixed with indigo carmine; and (3) circumferential incision. After completion of the submucosal injection and circumferential incision, the robotic arm will be deployed, and the end-effector grasper will grasp and lift the mucosal edge to provide a clear view of the dissection plane, after which submucosal dissection will be performed. Finally, the resected specimen will be retrieved using the FASTER system through the endoscope or via suction. Throughout the procedure, patients' vital signs and any procedure-related serious adverse events will be recorded for statistical analysis
Active Comparator: Conventional colorectal ESD; Conventional colorectal ESD - Patients undergo standard ESD using a transparent distal cap without robotic assistance.	Other: Conventional ESD group; In the control group, a transparent distal attachment cap will be mounted onto the tip of the endoscope at the beginning of the procedure. ESD will then be performed following the standard steps of conventional ESD, including: (1) lesion marking; (2) submucosal injection using normal saline mixed with indigo carmine; (3) circumferential incision; (4) submucosal dissection; and (5) retrieval of the resected specimen via suction. Throughout the procedure, patients' vital signs and any procedure-related serious adverse events will be recorded for statistical analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total procedure time	Measured from initiation of submucosal injection to completion of submucosal dissection.	Recorded intraoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
En bloc resection rate	Defined as whether the lesion was resected in a single piece, assessed immediately after resection by the endoscopist.	Periprocedural (intraoperative assessment)
Submucosal dissection time	Measured from completion of circumferential incision to complete removal of the lesion	Recorded intraoperatively
Robotic operational flexibility	Number of attempts required for successful grasp and number of accidental drops. Successful grasp defined as effective traction providing clear submucosal visualization.	Recorded intraoperatively
Dissection speed	Calculated as lesion area divided by dissection time. Lesion area is determined intraoperatively or from the resected specimen using the longest diameter (a) and the perpendicular diameter (b), applying the ellipse formula: area = a × b × π/4.	Periprocedural (from intraoperative measurement to postoperative calculation within 24 hours)
Incidence of device malfunction	Device malfunctions (arm jamming, vision interruption, waterway obstruction/leakage) will be recorded intraoperatively and expressed as events per total cases.	Recorded intraoperatively
Rates of intraoperative and postoperative complications	Intraoperative and postoperative complications such as bleeding, perforation, and muscularis propria injury will be documented. Based on established clinical diagnostic criteria and the corresponding medical records, these events will be assessed by the study investigators and recorded in the CRF.	Periprocedural (from intraoperative period through hospital discharge, up to 7 days)
Complete resection rate	Defined as en bloc resection with histologically tumor-free lateral and vertical margins (R0 resection).	Within 7 days post-procedure (upon pathology report issuance)

Collaborators and Investigators

• Sponsor: Kaiyun Liu

Study record dates

Study Major Dates

• Study Start (Estimated): January 6, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: January 4, 2026
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Randomized controlled trial (RCT); Colorectal lesions; Endoscopic Submucosal Dissection (ESD); FASTER robot; Procedure time
• Other Study ID Numbers: NYSZYYEC2025K111R002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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