Efficacy and Safety of the RDI Mode in Endoscopic Submucosal Dissection: a Multicenter, Randomized Controlled Study
| Registry | NCT07366489, acronym RM-ESD |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 158 (Estimated) |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University (Other); collaborators: Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangdong Second Provincial General Hospital |
| Conditions | Endoscopic Submucosal Dissection (ESD) |
| Interventions | RDI (Other) |
| Dates | start 2026-01-01 (estimated), primary completion 2027-12-31 (estimated), completion 2027-12-31 (estimated), first posted 2026-01-26, last updated 2026-01-26 |
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All trials for Endoscopic Submucosal Dissection (ESD) All trials of RDI
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| RDI group | Experimental | 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). |
| WLE group | No intervention | The WLE group completes the entire ESD procedure using only WLE, without switching to RDI. |
Sex: All, ages: 18 Years to any
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.