Endoscopic Submucosal Dissection Versus Gastrectomy
Long-term Outcomes of Endoscopic Submucosal Dissection Versus Gastrectomy for Early Gastric Cancer
1 other identifier
observational
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2003
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
August 9, 2014
CompletedFirst Posted
Study publicly available on registry
August 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedMay 20, 2015
May 1, 2015
11.6 years
August 9, 2014
May 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient's death
up to 5 years
Secondary Outcomes (2)
Tumor recurrence
up to 5 years
Development of metachronous cancers
up to 5 years
Study Arms (2)
Surgery group
Patients who underwent surgery as treatment of early gastric cancer
ESD group
Patients who underwent endoscopic submucosal dissection (ESD) as treatment of early gastric cancer, instead of surgery
Interventions
Surgery for early gastric cancer includes distal gastrectomy, total gastrectomy, proximal gastrectomy, and wedge resection
Eligibility Criteria
All patients with early gastric cancer were treated by surgery or ESD at a single, tertiary-care, academic medical center.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Soonchunhyang University Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jun-Hyung Cho, M.D.
Soonchunhyang University Hospital, Seoul, Korea
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 9, 2014
First Posted
August 13, 2014
Study Start
May 1, 2003
Primary Completion
December 1, 2014
Study Completion
March 1, 2015
Last Updated
May 20, 2015
Record last verified: 2015-05