NCT07366489: RM-ESD

Efficacy and Safety of the RDI Mode in Endoscopic Submucosal Dissection

Not yet recruiting NA Last updated 26 January 2026

What this trial tests

NA trial testing RDI in Endoscopic Submucosal Dissection (ESD) in 158 participants. Not yet recruiting.

Timeline

1 January 2026

Primary endpoint
31 December 2027

31 December 2027

Quick facts

Lead sponsor	Sixth Affiliated Hospital, Sun Yat-sen University
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	158
Start date	1 January 2026
Primary completion	31 December 2027
Estimated completion	31 December 2027

Drugs / interventions tested

• RDI

Conditions studied

• Endoscopic Submucosal Dissection (ESD) — all drugs for Endoscopic Submucosal Dissection (ESD) →

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Who can join

18 and older, any sex, with Endoscopic Submucosal Dissection (ESD). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.