Efficacy and Safety of the RDI Mode in Endoscopic Submucosal Dissection

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

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

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.