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

Summary

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.

Conditions

• Colorectal Lesions
• Endoscopic Submucosal Dissection (ESD)
• FASTER Robot

Interventions

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

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.

Sponsors & Collaborators

• Kaiyun Liu

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-06

Primary Completion

2026-07-30

Completion

2026-11-30