Efficacy and Safety of the RDI Mode in Endoscopic Submucosal Dissection: a Multicenter, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 158
- 主要终点
- mean resection speed (mm²/min) achieved with RDI versus conventional WLE during ESD
研究概览
简要总结
Conventional white-light endoscopy (WLE) is hampered by insufficient contrast when attempting to identify deep vessels and active bleeding sites; visibility drops further when blood pools or spurts obscure the field, resulting in significantly lower hemostatic efficiency. Red dichromatic imaging (RDI), a novel image-enhanced endoscopic modality, has recently been shown to improve the visualization of deep-lying vessels and bleeding points, shorten hemostasis time and potentially increase overall procedural efficiency.
Although retrospective series have suggested that RDI may facilitate intra-operative bleeding control and better delineation of the submucosal plane during endoscopic submucosal dissection (ESD), high-level evidence from multicenter, randomized, controlled trials (RCTs) is lacking. No study has yet demonstrated superiority over WLE with respect to critical endpoints such as en-bloc resection rate, procedure time, complication rate and operator mental workload.
The investigators therefore designed a multicenter RCT to systematically compare the efficacy and safety of full-procedural RDI with conventional WLE during ESD.
The primary outcome parameter is the mean resection speed (mm²/min) achieved with RDI versus conventional white-light endoscopy during ESD.
The secondary outcome parameters are: complete resection (R0) rate, en-bloc resection rate, resection margin, number of intra-procedural bleeding episodes, intra-procedural blood loss, intra-procedural hemostasis time, other intra-procedural adverse events, and post-procedural adverse events.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Early gastric cancer or precancerous lesions, early esophageal cancer or precancerous lesions, or early colorectal cancer/polyps that meet ESD indications.
- •ESD procedure to be performed at a participating center.
- •Lesion diameter 20-60 mm. ⑤ Written informed consent provided voluntarily.
排除标准
- •① Foreigners.
- •② Severe coagulopathy (platelet count <50×10⁹/L or INR >1.5), significant cardiopulmonary disease, or any other contraindication to endoscopic therapy.
- •③ Imaging evidence of distant metastasis or lymph-node metastasis.
研究组 & 干预措施
RDI group
Throughout the entire ESD dissection, the RDI mode is used continuously for submucosal dissection (while white-light endoscopy may be employed for observation and marking).
干预措施: RDI (Other)
WLE group
The WLE group completes the entire ESD procedure using only WLE, without switching to RDI.
结局指标
主要结局
mean resection speed (mm²/min) achieved with RDI versus conventional WLE during ESD
时间窗: Periprocedural
The resection speed is calculated as the area on the specimen-fixation board divided by the time elapsed from the first mucosal incision to complete dissection of the lesion.
次要结局
- complete resection (R0) rate(Periprocedural)
- en-bloc resection rate(Periprocedural)
- resection margin(Periprocedural)
- number of intra-procedural bleeding episodes(Periprocedural)
- intra-procedural blood loss(Periprocedural)
- intra-procedural hemostasis time(Periprocedural)
- other intra-procedural adverse events(Periprocedural)
- post-procedural adverse events(From enrollment to 30 days after the procedure.)