Actively Recruiting
Comparison of Endoscopic Submucosal Dissection and Surgery for Early Gastric Cancer With Undifferentiated Histological Type A Multicenter Randomized Controlled Trial
Led by National Cancer Center, Korea · Updated on 2024-12-27
708
Participants Needed
1
Research Sites
402 weeks
Total Duration
On this page
Sponsors
N
National Cancer Center, Korea
Lead Sponsor
S
Seoul St. Mary's Hospital, The Catholic University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to compare the clinical effectiveness and cost-effectiveness of endoscopic submucosal dissection (ESD) versus surgery for patients with early gastric cancer (EGC) of the undifferentiated type who meet specific expanded criteria. The study focuses on patients whose tumors are confined to the stomach lining without ulcers, are 2 cm or smaller, and show no signs of lymph node or distant metastasis. Previous studies suggested that ESD might offer better quality of life and lower medical costs than surgery, though surgery showed better disease-free survival in retrospective analyses. This trial seeks to provide stronger evidence through a multi-center, randomized controlled design.
CONDITIONS
Official Title
Comparison of Endoscopic Resection and Surgery for Early Gastric Cancer With Undifferentiated Histological Type
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with undifferentiated type early gastric cancer (signet ring cell carcinoma, poorly differentiated tubular adenocarcinoma, or poorly cohesive carcinoma) that meets expanded ESD criteria: tumor confined to the mucosa without ulcer and size 2 cm or less on endoscopy
- No evidence of lymph node or distant metastasis on abdominal CT scan
- Adults aged 19 to 75 years
- Willingness to sign an informed consent form
You will not qualify if you...
- Under 19 years or over 75 years of age
- Diagnosed and treated for other organ cancers (except carcinoma in situ and non-melanomatous skin cancer) within the past 5 years
- Previous gastrectomy or esophagectomy
- Multiple gastric cancers
- Current treatment for serious medical conditions that may interfere with study participation, including severe heart dysfunction, liver cirrhosis, renal failure, chronic obstructive pulmonary disease or asthma, or uncontrolled infection
- Unable to provide informed consent
- Considered unsuitable for study enrollment by study physicians
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, South Korea, 410-769
Actively Recruiting
Research Team
I
Il Ju Choi, MD, PhD
Y
Young-Il Kim, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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