Endoscopic Submucosal Dissection Versus Gastrectomy

Early Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02216110
• Other study ID #: SCHDDC-2014-01
• Status: Completed
• Phase: N/A
• First received: August 9, 2014
• Last updated: May 19, 2015
• Start date: May 2003
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Soonchunhyang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Early Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Hospital	SeouL

Sponsors (1)

Lead Sponsor	Collaborator
Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient`s death		up to 5 years	No
Secondary	Tumor recurrence		up to 5 years	No
Secondary	Development of metachronous cancers		up to 5 years	No