Advanced Gastric Cancer, Laparoscopic Gastrectomy
Conditions
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)
Interventions
PROCEDURELaparoscopic gastrectomy
Operative procedure: laparoscopic gastrectomy(D2 lymphadenectomy according to JGCA guideline and total omentectomy for tumor with serosa exposure)
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3 year recurrence free survival | Postoperative 3 year | Evaluation of recurrence after regular 3 months follow-up using tumor marker, chest x-ray, endoscopy and computed tomograhy. |
Countries
South Korea
Outcome results
None listed