Efficacy and Safety of the RDI Mode in Endoscopic Submucosal Dissection (RM-ESD)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Endoscopic Submucosal Dissection (ESD)
• Intervention / Treatment: Other: RDI

• Study Type: Interventional
• Enrollment (Estimated): 158
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jia C Sun, MM; Phone Number: 86-20-38379764; Email: sunjch8@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RDI group; 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).	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).
No Intervention: WLE group; The WLE group completes the entire ESD procedure using only WLE, without switching to RDI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean resection speed (mm²/min) achieved with RDI versus conventional WLE during ESD	The resection speed is calculated as the area on the specimen-fixation board divided by the time elapsed from the first mucosal incision to complete dissection of the lesion.	Periprocedural

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complete resection (R0) rate	complete resection (R0) rate	Periprocedural
en-bloc resection rate	en-bloc resection rate	Periprocedural
resection margin	vertical and horizontal resection margin	Periprocedural
number of intra-procedural bleeding episodes	number of intra-procedural bleeding episodes	Periprocedural
intra-procedural blood loss	intra-procedural blood loss	Periprocedural
intra-procedural hemostasis time	intra-procedural hemostasis time	Periprocedural
other intra-procedural adverse events	perforation, infection, and other adverse eventes	Periprocedural
post-procedural adverse events	perforation, infection, delayed gastrointestinal bleeding, and other adverse events,	From enrollment to 30 days after the procedure.

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
• Collaborators: Guangdong Provincial Hospital of Traditional Chinese Medicine; Guangdong Second Provincial General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 26, 2025
• First Submitted That Met QC Criteria: January 16, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: ESD; polyp; early cancer; RDI
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neoplasms; Polyps
• Other Study ID Numbers: 2025ZSLYEC-728

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No