Endoscopic Submucosal Dissection Versus Gastrectomy

NCT ID: NCT02216110

Last Updated: 2015-05-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-05-31
• Study Completion Date: 2015-03-31

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.

Conditions

Early Gastric Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Surgery group

Patients who underwent surgery as treatment of early gastric cancer

Surgery

Intervention Type: PROCEDURE

Surgery for early gastric cancer includes distal gastrectomy, total gastrectomy, proximal gastrectomy, and wedge resection

ESD group

Patients who underwent endoscopic submucosal dissection (ESD) as treatment of early gastric cancer, instead of surgery

No interventions assigned to this group

Interventions

Surgery

Surgery for early gastric cancer includes distal gastrectomy, total gastrectomy, proximal gastrectomy, and wedge resection

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Soonchunhyang University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jun-Hyung Cho

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jun-Hyung Cho, M.D.

Role: PRINCIPAL_INVESTIGATOR

Soonchunhyang University Hospital, Seoul, Korea

Locations

Soonchunhyang University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

SCHDDC-2014-01

Identifier Type: -

Identifier Source: org_study_id