Early Gastric Cancer Clinical Trial
Official title:
Long-term Outcomes of Endoscopic Submucosal Dissection Versus Gastrectomy for Early Gastric Cancer
Verified date | May 2015 |
Source | Soonchunhyang University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Institutional Review Board |
Study type | Observational |
Gastrectomy is curative treatment for early gastric cancer (EGC). Recently, endoscopic submucosal dissection (ESD) has been accepted as standard treatment in selected patients with negligible risk of lymph node metastasis. However, there are limited data regarding the long-term outcomes of ESD in comparison with surgery. This protocol aims to compare overall survival rate, tumor recurrence, development of metachronous cancers after ESD and surgery.
Status | Completed |
Enrollment | 500 |
Est. completion date | March 2015 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 80 Years |
Eligibility |
Inclusion Criteria: - differentiated type mucosal cancer without ulceration, regardless of tumor size - differentiated type mucosal cancer with ulceration = 3 cm in diameter - superficial (SM1 < 500 µm) submucosal cancer = 3 cm in diameter - undifferentiated type mucosal cancer without ulceration = 2 cm in diameter Exclusion Criteria: - early gastric cancer in a remnant stomach - gastrectomy due to metachronous lesions during follow-up period - post-ESD additional surgery due to high risk of lymph node metastasis or the possibility of residual tumor |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Soonchunhyang University Hospital | SeouL |
Lead Sponsor | Collaborator |
---|---|
Soonchunhyang University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient`s death | up to 5 years | No | |
Secondary | Tumor recurrence | up to 5 years | No | |
Secondary | Development of metachronous cancers | up to 5 years | No |
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