Impact of full-time RDI on major adverse events and procedure time during endoscopic submucosal dissection for early gastric cancer or gastric adenoma
Official title: The Effect of Full-time RDI on the Incidence of Major Adverse Intraoperative or Delayed Events and the Proportion of ESD Procedures With Prolonged Procedure Time: A Multicenter Prospective Randomized Controlled Trial
Run by Xijing Hospital of Digestive Diseases · NCT07401303 · Data updated 2026-11-12
This study tests whether using Red Dichromatic Imaging (RDI) during endoscopic submucosal dissection (ESD) can reduce major adverse events and shorten procedure time for adults with early gastric cancer or gastric adenoma.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 640 (estimated) |
| Sponsor | Xijing Hospital of Digestive Diseases Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Xi'an, Shaanxi) |
| Status | Recruiting |
| Started | March 1, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | January 31, 2028 |
| Registry record updated | August 17, 2026 |
| Trial ID | NCT07401303 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–75 with suspected or confirmed early gastric cancer or gastric adenoma scheduled for ESD and able to discontinue antithrombotic therapy per guidelines.
✕Probably not a fit
Patients with contraindications to antithrombotic withdrawal, complex lesions requiring non-standard approaches, or those not fitting inclusion criteria may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study evaluates the use of Red Dichromatic Imaging (RDI) during ESD for early gastric cancer or gastric adenoma. RDI is expected to improve visualization of deep vessels and active bleeding, potentially reducing complications and guiding faster dissection. Participants are adults aged 18–75 scheduled for ESD and meet predefined bloodwork and antithrombotic guidelines. The trial compares outcomes with and without RDI-assisted imaging, focusing on major adverse events and procedure duration. Safety monitoring and standardized techniques are incorporated across participating centers.
Why it matters
Potential benefit: If successful, RDI-assisted ESD could lower bleeding risks and shorten procedure times for patients undergoing ESD.
How similar studies have gone: Prior imaging enhancements for ESD have shown promise in improving visualization, but results with RDI are still being explored and this study contributes new evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where it's running
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The First Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, China Recruiting
Study contacts
- Study coordinator: Hui Chen, MD, PhD
- Email: qychenhui@163.com
- Phone: 02984771535
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.