Clinical Utility and Validation of Novel AI-ENDO System in Endoscopic Submucosal Dissection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Technical success rate
研究概览
简要总结
This study is a pilot trial designed to evaluate the feasibility and safety of Al-ENDO assisted ESD in patients with gastrointestinal superficial lesions. Patients with gastrointestinal superficial lesions are scheduled for conventional ESD will be screened for eligibility. The study consists of a few stages:
- In the first phase, the Al-ENDO system will be tested in the background of the ESD procedure prospectively, but without interfering the endoscopists. The Al-ENDO system would be installed in the Endoscopy Centre in Prince of Wales Hospital. Real-time video analysis would be conducted in the background without interference of the endoscopists' performance. A total of 30 clinical ESD procedures would be analysed, with the goal of achieving good accuracy of the system. The data obtained from this group of patients would also serve as control group for comparison with the subsequent procedures with Al-ENDO support.
- The second phase of the study would comprise of a the prospective pilot study which Al-ENDO system would be connected to the endoscopy tower with the auxiliary output monitor placing side-by-side with the endoscopy main monitor. The GUI would be displayed in the auxiliary monitor. This phase aims to demonstrate device and patients' safety throughout the procedure, and a total of 10 patients would be recruited, with the target of ensuring smooth dissection procedure without system interruption of failure. In this phase of the study, only expert endoscopist would be involved in performing the procedure.
- The third phase of the study comprises of a continuation of the initial pilot study with additional of 20 more patients, so that total of 30 procedures would be performed to compare the clinical outcomes with the control group collected previously.
详细描述
Gastrointestinal (GI) cancer, including stomach, colorectal, and esophageal cancer, is collectively the most common cancer worldwide and the leading cause of cancer-related death globally. The disease imposes a significant burden in Hong Kong, with more than 6,000 new cases diagnosed annually according to local cancer statistics. Despite substantial advances in understanding its pathology, molecular mechanisms, and therapeutic strategies, the survival rate of advanced GI cancer remains suboptimal, with a 5-year survival rate below 60% for most malignancies.
The introduction of government-led initiatives and international cancer policies has expanded early GI cancer screening programs, enabling more patients to be diagnosed at an earlier stage. Early detection allows for less-invasive and more effective treatment options with improved prognosis and increased curative surgical rates.
Complete tumor resection remains the only curative approach for localized GI cancer. Endoscopic submucosal dissection (ESD), a minimally invasive endoscopic technique, has become an established method for early-stage cancers confined to the mucosal layer. ESD enables en-bloc resection of lesions, achieving lower local recurrence rates compared with conventional endoscopic mucosal resection. It has also demonstrated favorable perioperative outcomes, including shorter operative time, lower complication rates, and reduced hospital stay. In countries where screening programs are well implemented, such as Japan, the number of ESD procedures now exceeds radical gastrectomies, making ESD the preferred treatment modality for early gastric cancer. ESD is also used for the treatment of pre-malignant lesions in the GI tract, preventing progression to invasive cancer.
An ESD procedure involves four main phases: (1) marking of the targeted lesion, (2) submucosal injection to create a protective cushion, (3) circumferential incision, and (4) submucosal dissection and removal of the lesion. Although ESD enables complete resection of lesions regardless of size and has a recurrence rate below 1%, it remains technically demanding and carries risks such as bleeding and perforation. In regions where ESD adoption is lower, the learning curve may exceed several hundred cases before proficiency is achieved. Increasing international guidance and training efforts have encouraged a global expansion in the use of ESD as its clinical benefits become more widely recognized.
Safe and precise dissection of cancerous tissue within the complex gastrointestinal environment is critical. Medical safety events in surgical practice contribute significantly to excess hospital stays, costs, and mortality. ESD is technically challenging, requiring endoscopists to maintain clear visualization of the submucosal layer while preserving a stable endoscopic field. Anatomical complexities such as colon flexures, thin colonic walls, mucosal folds, and peristalsis further increase the difficulty of colorectal ESD and raise the risk of incomplete dissection and perforation. Given these challenges, there is a clear need for advanced technologies that enhance surgical precision and safety through intelligent intraoperative guidance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Patient with superficial esophageal, gastric or colorectal lesions, scheduled for endoscopic submucosal dissection (ESD).
- •Age between 18 and 85.
排除标准
- •Patient who refused to participate.
- •Other cases deemed by the examining physician as unsuitable for safe treatment.
研究组 & 干预措施
AI-ENDO assisted ESD
ESD performed with AI-ENDO assistance
干预措施: AI-ENDO system (Device)
AI-ENDO assisted ESD
ESD performed with AI-ENDO assistance
干预措施: Conventional ESD (Procedure)
Conventional ESD
ESD performed as in usual clinical practice
干预措施: Conventional ESD (Procedure)
结局指标
主要结局
Technical success rate
时间窗: 1 day
Defined as the rate of procedure with successful en-bloc, without major intra-operative adverse event. Unit of measure: % of procedures
次要结局
- Clinical success rate(30 days)
- Total procedure time(1 day)
- Resected lesion size(1 day)
- Lesion location(1 day)
- Lesion histological type(30 days)
- NASA Task Load Index(1 day)
- Overall rate of intraprocedural adverse events(1 day)
- Rate of intraprocedural adverse events - partial thickness muscle injury(1 day)
- Rate of intraprocedural adverse events - full thickness perforation(1 day)
- Rate of intraprocedural adverse events - haemorrhage(1 day)
- Rate of intraprocedural adverse events - Peritonitis(1 day)
- Rate of intraprocedural adverse events - others(1 day)
- Overall rate of post-procedural adverse events(30 days)
- Rate of postprocedural adverse events - Electrocoagulation syndrome(30 days)
- Rate of post-procedure adverse events - delayed haemorrhage(30 days)
- Rate of post-procedure adverse events - delayed perforation(30 days)
- Rate of post-procedure adverse events - others(30 days)
- AI-system of latency(1 day)
- AI system accuracy (pixel accuracy)(1 day)
- AI system accuracy (Dice similarity coefficient)(1 day)
研究者
Hon Chi Yip
Assistant Professor
Chinese University of Hong Kong
