Efficacy and Safety of the RDI Mode in Endoscopic Submucosal Dissection

NCT07366489 | Not Yet Recruiting DMC

• 1 other identifier: 2025ZSLYEC-728
• Study Type: interventional
• Target: 158
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Endoscopic Submucosal Dissection (ESD)

Keywords

ESD; RDI; early cancer; polyp

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• complete resection (R0) rate

  Periprocedural

• en-bloc resection rate

  Periprocedural

• resection margin

  Periprocedural

• number of intra-procedural bleeding episodes

  Periprocedural

• intra-procedural blood loss

  Periprocedural

Study Arms (2)

RDI group

EXPERIMENTAL

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

WLE group

NO INTERVENTION

The WLE group completes the entire ESD procedure using only WLE, without switching to RDI.

Interventions

RDI OTHER

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).

RDI group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead
• Guangdong Provincial Hospital of Traditional Chinese Medicine: collaborator
• Guangdong Second Provincial General Hospital: collaborator

MeSH Terms

Conditions

Neoplasms; Polyps

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jia C Sun, MM

CONTACT

86-20-38379764; sunjch8@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2025
• First Posted: January 26, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share