Effect of Simplified Robot (FASTER) Assisted Versus Conventional Endoscopic Submucosal Dissection (ESD) for Colorectal Lesions: A Prospective, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
This is a single-blind study in which the outcomes assessor is blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years.
- •Patients with colorectal lesions scheduled to undergo endoscopic submucosal dissection (ESD)
- •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;
- •Willingness to participate in the study and provision of written informed consent.
排除标准
- •Suspected deep submucosal invasive carcinoma based on endoscopic features；
- •Lesions presenting with non-lifting signs, suggesting deep submucosal invasive carcinoma or tumors with severe submucosal fibrosis;
- •Lesions extending to the appendiceal orifice, colonic diverticulum, or ileocecal valve; (4) Pregnant women or women who may be pregnant; lactating women;
- •Pregnant women or women who may be pregnant; lactating women;
- •Patients with coagulation disorders;
- •Patients considered ineligible for specific reasons;
- •Patients with contraindications to anesthesia and/or colonoscopy. -
研究者
Kaiyun Liu
Principal Investigator, Clinical Professor
Shenzhen Hospital of Southern Medical University