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

RecruitingNAAges 18 Years - 75 YearsAllXijing Hospital of Digestive Diseases
NCT07401303 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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8.0 g/L in blood tests performed in the 3 months before the ESD * "antithrombotic drugs" have been withdrawn for the period recommended by current guidelines * written consent provided at the patient's discretion Exclusion Criteria: * scheduled for hybrid ESD *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
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What it tests

  • ESD
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Where

1 site
The First Affiliated Hospital of Air Force Medical University
Xi'an, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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