Endoscopic Submucosal Dissection Versus Gastrectomy

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.

Study Overview

• Status: Completed
• Conditions: Early Gastric Cancer
• Intervention / Treatment: Procedure: 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.

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Korea, Republic of
  • SeouL, Korea, Republic of
    • Soonchunhyang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients with early gastric cancer were treated by surgery or ESD at a single, tertiary-care, academic medical center.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgery group; Patients who underwent surgery as treatment of early gastric cancer	Procedure: Surgery; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient's death	up to 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Tumor recurrence	up to 5 years
Development of metachronous cancers	up to 5 years

Collaborators and Investigators

• Sponsor: Soonchunhyang University Hospital
• Investigators: Principal Investigator: Jun-Hyung Cho, M.D., Soonchunhyang University Hospital, Seoul, Korea

Study record dates

Study Major Dates

• Study Start: May 1, 2003
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: August 9, 2014
• First Submitted That Met QC Criteria: August 12, 2014
• First Posted (Estimate): August 13, 2014

Study Record Updates

• Last Update Posted (Estimate): May 20, 2015
• Last Update Submitted That Met QC Criteria: May 19, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Survival; Endoscopic submucosal dissection; Outcome; Gastrectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: SCHDDC-2014-01