Efficacy and Safety of the RDI Mode in Endoscopic Submucosal Dissection

Official title

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

Overview

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.

Interventions

• Other 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).

Primary outcome measures

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

Secondary outcome measures (8)

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07366489 · 2025ZSLYEC-728

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗