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Recruiting Not applicable

Comparison of Endoscopic Resection and Surgery for Early Gastric Cancer With Undifferentiated Histological Type

NCT04890171 · tracked via the Priya Life Science South Korea tracker
Phase
Not applicable
Started
2021-06-11
Last updated
2024-12-27

Condition(s) studied

Stomach CancerUndifferentiated TypeExpanded Indication of Endoscopic Resection

Investigational drug(s) / intervention(s)

Endoscopic submucosal dissectionSurgery

Endoscopic submucosal dissection: Endoscopic submucosal dissection by a endoscopist using endoscopic devices

Surgery: Gastrectomy with lymph node dissection by a surgeon

Study summary

This multi-center, randomized controlled trial is designed to evaluate clinical effectiveness and cost-effectiveness of ESD for undifferentiated type of EGC meeting the expanded indication compared with surgery.

Eligibility

Sex
ALL
Min age
19 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients who are diagnosed with undifferentiated type EGC (signet ring cell carcinoma, poorly differentiated tubular adenocarcinoma, or poorly cohesive carcinoma) that meets the expanded indication of ESD 1) Tumor confined to the mucosa without ulcer, and size ≤2 cm on endoscopic evaluations 2) No evidence of lymph node metastasis and distant metastasis on abdominal CT scan 2. Adult patients aged 19-75 years 3. Patients who had willingness to sign an informed consent form Exclusion Criteria: 1. Patient age: \< 19 years or age \> 75 years 2. Diagnosis and active treatment for other organ cancer except carcinoma in situ and non-melanomatous skin cancer within 5 years 3. Previous gastrectomy or esophagectomy history 4. Multiple gastric cancers 5. Current treatment for serious medical condition which could hinder study participation including severe heart dysfunction, liver cirrhosis, renal failure, chronic obstructive pulmonary disease or asthma, or uncontrolled infection 6. Inability to provide an informed consent 7. Inadequate conditions for study enrollment according to the evaluation of study physicians

Primary outcome measure(s)

  • 3-year disease-free survival in the ITT population — 3 years after the last participant enrollment
    Disease-free survival (gastric cancer recurrence or death from any causes)

Trial sites (1)

FacilityCityRegionStatus
National Cancer Center, Korea Goyang-si Gyeonggi-do Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04890171 on ClinicalTrials.gov ↗ ← All trials in South Korea