This trial is active, not recruiting.

Conditions advanced gastric cancer, laparoscopic gastrectomy
Treatment laparoscopic gastrectomy
Phase phase 2
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Laparoscopic gastrectomy procedure: D2 lymphadenectomy & total omentectomy in case of tumor with serosa exposure under laparoscopic exploration
laparoscopic gastrectomy
Operative procedure: laparoscopic gastrectomy(D2 lymphadenectomy according to JGCA guideline and total omentectomy for tumor with serosa exposure)

Primary Outcomes

3 year recurrence free survival
time frame: Postoperative 3 year

Eligibility Criteria

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

Additional Information

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)
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Seoul National University Bundang Hospital.