Early Gastric Cancer Clinical Trial
Official title:
Long-term Outcomes of Endoscopic Submucosal Dissection Versus Gastrectomy for Early Gastric Cancer
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.
The prevalence of gastric cancer is high in Asia, especially in Korea and Japan. In Korea,
the detection rate of EGC has increased with mass screening for the prevention of gastric
cancer-related death. EGC is defined as mucosal or submucosal cancer, regardless of regional
lymph node metastasis. The presence of lymph node metastasis has been reported to range from
2% to 18%. For this reason, radical gastrectomy with lymph node dissection was considered as
the only curative treatment. In EGC patients, surgical outcome demonstrated excellent 5-year
survival rate above 90%.
In 2000, EGC subgroups with negligible risk of lymph node metastasis were proposed on the
basis of large scale retrospective data. Thereafter, the result was adopted as expanded
criteria for endoscopic resection of EGC. ESD is useful technique to dissect the tumor along
the submucosal layer using various endoscopic knives. Compared to endoscopic mucosal
resection (EMR), ESD achieved a higher complete resection rate and a lower local tumor
recurrence rate.
Although curative resection is pathologically achieved by ESD, post-resection surveillance
is needed to confirm the presence of nodal metastasis. Recently, several studies reported
that 5-year overall and disease-specific survival rate were highly favorable in EGC patients
who underwent curative ESD. However, there is no comparative study about long-term outcomes
after ESD and gastrectomy. Therefore, this protocol aims to evaluate overall survival rate,
tumor recurrence, development of metachronous cancers between ESD and surgery groups.
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Observational Model: Cohort, Time Perspective: Retrospective
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