Comparing endoscopic resection and surgery for early gastric cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multi-center, randomized controlled trial evaluates the clinical effectiveness and cost-effectiveness of endoscopic submucosal dissection (ESD) for undifferentiated type early gastric cancer (EGC) compared to traditional surgery. ESD is a minimally invasive procedure that preserves the stomach and may offer a better quality of life and lower medical costs for patients. The study focuses on patients with tumors confined to the mucosa, measuring ≤2 cm, and aims to provide evidence on the long-term outcomes of ESD versus surgery. Previous studies have suggested favorable outcomes for ESD, making this trial crucial for validating its expanded indication.

Why it matters

Who can join: the full rules

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

Where it's running

• National Cancer Center, Korea
  Goyang-si, Gyeonggi-do, South Korea Recruiting

Study contacts

• Principal investigator: Il Ju Choi, MD, PhD — National Cancer Center, Korea
• Study coordinator: Il Ju Choi, MD, PhD
• Email: cij1224@ncc.re.kr
• Phone: +82-31-920-2282

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.