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

Launched by NATIONAL CANCER CENTER, KOREA · May 15, 2021

Keywords

ClinConnect Summary

This clinical trial is comparing two treatment options for early gastric cancer (stomach cancer) that has a specific type of cells called undifferentiated type. The main goal is to see if a less invasive procedure called endoscopic submucosal dissection (ESD) is as effective and cost-effective as traditional surgery for patients with tumors that are small (2 cm or less) and have not spread. The trial is currently looking for participants aged 19 to 75 who have been diagnosed with this type of stomach cancer and meet certain health criteria.

If you decide to join this trial, you will be randomly assigned to either the ESD or surgery group. Participants will receive careful monitoring and support throughout the study. It's important to know that this trial is focused on patients who have specific types of undifferentiated gastric cancer without any major complications or other active cancers. By taking part in this research, you may help improve treatment options for future patients with similar conditions.

Gender

ALL

Eligibility criteria

• 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