Laparoscopic Gastrectomy for Advanced Gastric Cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Advanced Gastric Cancer
- Sponsor
- Seoul National University Bundang Hospital
- Enrollment
- 204
- Locations
- 1
- Primary Endpoint
- 3 year recurrence free survival
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
Although laparoscopic gastrectomy (LG) is widely used for the treatment of early gastric cancer, there have been few reports of the efficacy of LAG in the management of advanced gastric cancer(AGC). The aim of this study is to evaluate the surgical outcomes and oncologic safety of laparoscopic gastrectomy for AGC.
Detailed Description
Prospective phase II clinical trial to evaluate technical and oncological safety of LG for AGC LG procedure for AGC: D2 lymphadenectomy Total omentectomy for tumor with serosa exposure under laparoscopic exploration Primary end point: 3 year disease free survival secondary end point: postoperative outcomes, morbidity and mortality, 3,5 and 7 year overall survival, Quality of life, recurrence pattern Study duration: 7 years(enrollment: 4year, follow-up: 3year)
Investigators
Hyung-Ho Kim
Principal Investigator
Seoul National University Bundang Hospital
Eligibility Criteria
Inclusion Criteria
- •Age 20-80
- •informed consent
- •no other malignancies
- •cT2N0-cT3N2 according to JGCA 2nd edition
- •ASA score\<3
Exclusion Criteria
- •distant metastasis(P1 or M1) under laparoscopic exploration
- •Conglomerated N2
- •early gastric cancer in permanent pathologic report
Outcomes
Primary Outcomes
3 year recurrence free survival
Time Frame: Postoperative 3 year
Evaluation of recurrence after regular 3 months follow-up using tumor marker, chest x-ray, endoscopy and computed tomograhy.