NCT02216110

Endoscopic Submucosal Dissection Versus Gastrectomy

Long-term Outcomes of Endoscopic Submucosal Dissection Versus Gastrectomy for Early Gastric Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 500 (actual)
• Sponsor: Soonchunhyang University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Early Gastric Cancer

Interventions

Type	Name	Description
PROCEDURE	Surgery	Surgery for early gastric cancer includes distal gastrectomy, total gastrectomy, proximal gastrectomy, and wedge resection

Timeline

• Start date: 2003-05-01
• Primary completion: 2014-12-01
• Completion: 2015-03-01
• First posted: 2014-08-13
• Last updated: 2015-05-20

Locations

1 site across 1 country: South Korea