Laparoscopic Gastrectomy for Advanced Gastric Cancer
This trial is active, not recruiting.
|Conditions||advanced gastric cancer, laparoscopic gastrectomy|
|Sponsor||Seoul National University Bundang Hospital|
|Start date||November 2008|
|End date||May 2012|
|Trial size||200 participants|
|Trial identifier||NCT01441336, SNUBHGS02|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
3 year recurrence free survival
time frame: Postoperative 3 year
Male or female participants from 20 years up to 80 years old.
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
|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)|
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