Efficacy and Safety of Robot-assisted Endoscopic Submucosal Dissection for Colorectal Neoplasm: A 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
- 104
- 试验地点
- 1
- 主要终点
- procedure time
研究概览
简要总结
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.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-
- •Patients with pathologically verified colorectal neoplasms scheduled to undergo ESD.
排除标准
- •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.
研究组 & 干预措施
Conventional ESD
Patients in this group undergo ESD following the clinically established pattern.
干预措施: Conventional ESD (Procedure)
FASTER-assisted ESD
Patients in this group undergo ESD with the assistance of the FASTER system.
干预措施: FASTER-assisted ESD (Procedure)
结局指标
主要结局
procedure time
时间窗: Within 24 hours after the procedure.
Procedure time is the time from the beginning of injection to the completion of dissection.
次要结局
- 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.)
- postoperative hemorrhage rate(Within 24 hours after the procedure.)
- intraoperative hemorrhage rate(Within 24 hours after the procedure.)
- the proportion of intraoperative hemorrhage ≥ grade 2(Within 24 hours after the procedure.)
- hemostasis time(Within 24 hours after the procedure.)
- muscular injury rate(Within 24 hours after the procedure.)
- direct-vision dissection rate(Within 24 hours after the procedure.)
- postoperative pain score(3 days after the procedure.)
- the frequency of supplemental injections(Within 24 hours after the procedure.)
- the supplemental injections time(Within 24 hours 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.)
研究者
Xiuli Zuo
Professor, MD, PhD
Shandong University