Full-time RDI for ESD: Impact on Major Adverse Events and Procedure Time

NCT07401303 | Not Yet Recruiting

• 1 other identifier: XJ-ESD-RDI
• Study Type: interventional
• Target: 640
• Locations: 1 country
• Sites: 1

Brief Summary

Gastric cancer remains a major global health burden, ranking fifth in incidence worldwide and disproportionately affecting Asia, with China accounting for a significant share of cases and deaths. Early detection and minimally invasive treatment are critical to improving outcomes. Endoscopic submucosal dissection (ESD) is the preferred curative approach for early gastric cancer, enabling precise, en bloc tumor resection while preserving gastric function. However, ESD is technically complex, time-consuming, and associated with risks such as intraoperative and delayed bleeding and perforation. These complications limit its widespread adoption, particularly outside East Asia. Traditional ESD relies on white light imaging (WLI), which offers limited visualization of submucosal vessels and bleeding sources. Red Dichromatic Imaging (RDI) is an emerging image-enhanced endoscopy technology that uses specific narrow-band wavelengths to enhance the contrast of deep blood vessels and active bleeding sites by exploiting hemoglobin's optical absorption characteristics. Preliminary studies indicate that RDI improves bleeding point identification, facilitates hemostasis, and reduces endoscopists' procedural stress. However, prior research applied RDI only intermittently during bleeding events, leaving its potential benefits throughout the entire ESD procedure unexplored. The "full-time RDI" concept proposes continuous use of RDI during all ESD stages-including submucosal injection, mucosal incision, dissection, and wound management-to enhance visualization of high-risk vessels, improve layer differentiation, and potentially reduce adverse events and operation time. Despite promising retrospective data, robust prospective evidence from large randomized controlled trials is lacking. This multicenter, prospective randomized controlled trial aims to evaluate whether full-course RDI reduces major intraoperative and delayed complications and decreases unexpectedly prolonged operation times compared to conventional WLI-guided ESD in early gastric cancer. Secondary endpoints include procedural efficiency, safety across lesion locations, and operator stress. By rigorously assessing full-time RDI's clinical value, this study addresses an urgent unmet need to improve ESD safety and efficiency, potentially broadening its application and enhancing patient outcomes. The innovation lies in integrating continuous advanced imaging throughout ESD, representing a significant advancement in endoscopic oncology and minimally invasive gastric cancer treatment.

Conditions

Early Gastric Cancer or Gastric Adenoma

Keywords

endoscopic submucosal dissection; ESD; red dichromatic imaging; RDI; bleeding; perforation

Outcome Measures

Primary Outcomes (1)

• the incidence of major intraoperative or delayed adverse events and/or ESD procedures with operation time exceeding the expected duration

  Major adverse events include use of hemostatic forceps for bleeding control, significant delayed bleeding, and perforation during or after ESD. Hemostatic forceps are used if bleeding persists after three electrocautery attempts or if the operator deems electrocautery insufficient. Delayed bleeding occurs mostly within 48 hours, marked by clinical signs needing hemostasis or transfusion, or \>20 g/L hemoglobin drop. Perforation is diagnosed by visible gastric wall defects or post-ESD peritoneal irritation with free gas on imaging. Expected ESD time (min) = 2.384 × tumor size (mm) + 38.568 × location (1=upper third, 0=others) + 40.333 × ulcer presence (1=yes, 0=no). Procedures exceeding 110% of this time are analyzed by lesion and specimen size.

  From enrollment to the end of treatment at 4 weeks

Secondary Outcomes (12)

• Incidence of major intraoperative or delayed adverse events

  From enrollment to the end of treatment at 4 weeks

• Incidence of ESD procedures exceeding 110% of the expected procedure time

  Throughout the ESD procedure

• Number of ESD procedures requiring hemostatic forceps for hemostasis

  Throughout the ESD procedure

• Number of hemostatic forceps uses during ESD

  Throughout the ESD procedure

• Number of hemostatic interventions during the procedure (regardless of type)

  Throughout the ESD procedure

Study Arms (2)

Full-time RDI

EXPERIMENTAL

Full-time Red Dichromatic Imaging (RDI) refers to the continuous application of RDI technology throughout the entire endoscopic submucosal dissection (ESD) procedure. This approach encompasses all procedural phases, including submucosal injection, circumferential mucosal incision, submucosal dissection, and post-resection wound management, with the aim of enhancing visualization of submucosal vessels and bleeding sources in real time to improve hemostasis, reduce complications, and increase procedural efficiency.

Procedure: ESD

Full-time WLI

ACTIVE COMPARATOR

Full-time White Light Imaging (WLI) refers to the continuous use of standard white light endoscopic imaging throughout the entire endoscopic submucosal dissection (ESD) procedure. This conventional approach involves relying solely on white light visualization during all stages of the procedure-including submucosal injection, mucosal incision, submucosal dissection, and post-resection wound assessment-without the aid of enhanced imaging modalities for vessel or bleeding source identification.

Procedure: ESD

Interventions

ESD PROCEDURE

Endoscopic Submucosal Dissection (ESD) is a minimally invasive endoscopic technique used to remove early-stage gastrointestinal tumors and precancerous lesions en bloc. Developed initially for the treatment of early gastric cancer, ESD allows for precise dissection of the submucosal layer beneath the lesion, enabling complete resection with clear margins while preserving the integrity of the surrounding tissue. This technique offers advantages over traditional endoscopic mucosal resection (EMR) by enabling the removal of larger and more complex lesions, reducing recurrence rates, and minimizing the need for invasive surgery.

Also known as: Endoscopic Submucosal Dissection

Full-time RDI; Full-time WLI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• scheduled to undergo ESD for an early gastric cancer (the indication for ESD under current guidelines)
• both genders aged 18-75 years
• no pretreatment (ESD, surgery, radiation therapy, or chemotherapy) performed on the stomach to be examined
• platelet count of \>10×10\^9/L and hemoglobin count of \>8.0 g/L in blood tests performed in the 3 months before the ESD
• "antithrombotic drugs" have been withdrawn for the period recommended by current guidelines
• written consent provided at the patient's discretion

You may not qualify if:

• scheduled for hybrid ESD
• scheduled for ESD due to multiple lesions
• scheduled for treatment of lesions with residual recurrence
• presence of submucosal tumors
• unable to discontinue an antithrombotic drugs at the time of informed consent
• inherited or acquired coagulopathy likely to affect the risk of bleeding
• receiving maintenance dialysis
• deemed unsuitable for participation in this study by the principal investigator or other investigators
• unable to provide informed consent

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (1)

The First Affiliated Hospital of Air Force Medical University

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Stomach Neoplasms; Hemorrhage

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Hui Chen, MD, PhD

CONTACT

02984771535; qychenhui@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 10, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

CN (1)