Efficacy and Safety of the RDI Mode in Endoscopic Submucosal Dissection

Официальное название

Efficacy and Safety of the RDI Mode in Endoscopic Submucosal Dissection: a Multicenter, Randomized Controlled Study

Обзор

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.

Вмешательства

• Другое RDI
  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).

Первичные конечные точки

• mean resection speed (mm²/min) achieved with RDI versus conventional WLE during ESD [Срок оценки: Periprocedural]

Вторичные конечные точки (8)

• complete resection (R0) rate [Срок оценки: Periprocedural]
• en-bloc resection rate [Срок оценки: Periprocedural]
• resection margin [Срок оценки: Periprocedural]
• number of intra-procedural bleeding episodes [Срок оценки: Periprocedural]
• intra-procedural blood loss [Срок оценки: Periprocedural]
• intra-procedural hemostasis time [Срок оценки: Periprocedural]
• other intra-procedural adverse events [Срок оценки: Periprocedural]
• post-procedural adverse events [Срок оценки: From enrollment to 30 days after the procedure.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07366489 · 2025ZSLYEC-728

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗