Early Gastric Cancer
Conditions
Keywords
Endoscopic submucosal dissection, Gastrectomy, Survival, Outcome
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURESurgery
Surgery for early gastric cancer includes distal gastrectomy, total gastrectomy, proximal gastrectomy, and wedge resection
Sponsors
Soonchunhyang University Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient's death | up to 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Tumor recurrence | up to 5 years |
| Development of metachronous cancers | up to 5 years |
Countries
South Korea
Outcome results
None listed