Status:
RECRUITING
Comparison of Endoscopic Resection and Surgery for Early Gastric Cancer With Undifferentiated Histological Type
Lead Sponsor:
National Cancer Center, Korea
Collaborating Sponsors:
Seoul St. Mary's Hospital, The Catholic University
Chilgok Kyungpook National University Hospital
Conditions:
Stomach Cancer
Undifferentiated Type
Eligibility:
All Genders
19-75 years
Phase:
NA
Brief 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 wi...
Detailed Description
Endoscopic submucosal dissection (ESD) is a minimally invasive treatment of early gastric cancer (EGC). Because of the stomach preservation, ESD provides a better quality of life (QoL) in EGC patients...
Eligibility Criteria
Inclusion
- 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
- Adult patients aged 19-75 years
- Patients who had willingness to sign an informed consent form
Exclusion
- Patient age: \< 19 years or age \> 75 years
- Diagnosis and active treatment for other organ cancer except carcinoma in situ and non-melanomatous skin cancer within 5 years
- Previous gastrectomy or esophagectomy history
- Multiple gastric cancers
- 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
- Inability to provide an informed consent
- Inadequate conditions for study enrollment according to the evaluation of study physicians
Key Trial Info
Start Date :
June 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2029
Estimated Enrollment :
708 Patients enrolled
Trial Details
Trial ID
NCT04890171
Start Date
June 11 2021
End Date
February 28 2029
Last Update
December 27 2024
Active Locations (1)
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1
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, South Korea, 410-769