Gastric Cancer
Conditions
Brief summary
The purpose of this study is to evaluate the oncological feasibility of laparoscopy-assisted distal gastrectomy with D2 lymph node dissection for advanced gastric cancer.
Detailed description
To test oncological feasibility, compliance of nodal dissection was selected as a primary end point. When there are more than two missing nodal station(no lymph nodes in dissected area), it is defined as a non-compliant nodal dissection. Other secondary outcomes will be supplementary to evaluate feasibility of D2 dissection.
Interventions
laparoscopy assisted distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer
PROCEDUREopen distal gastrectomy
open distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer
Sponsors
National Cancer Center, Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* histologically proven primary gastric adenocarcinoma * T2 or T3 or T4a, N0 or N1 or N2 or N3a (AJCC 7th), which is assessed by computed tomography (CT) scan - mid 1/3 or low 1/3 location * No evidence of other distant metastasis * not stump carcinoma,(vi) aged 20-80 year old * performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale * no prior treatment of chemotherapy or radiation therapy against any other malignancies, and no prior treatment for gastric cancer including endoscopic mucosal resection * adequate organ functions defined as indicated below: * WBC 3000/mm3, WBC 12 000/mm3 * Hb 8.0 g/dl without any transfusion 2 weeks before enrollment * Plt 100 000/mm3 * AST 100 IU/l * ALT 100 IU/l * T.Bil 2.0 mg/dl * written informed consent
Exclusion criteria
* active double cancer (synchronous double cancer and metachronous double cancer within five disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) * pregnant or breast-feeding women * severe mental disorder * systemic administration of corticosteroids * unstable angina or myocardial infarction within 6 months of the trial * unstable hypertension * severe respiratory disease requiring continuous oxygen therapy * previous upper abdominal surgery except laparoscopic cholecystectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| noncompliance rate | postoperative 1 week | A Case will be designated as noncompliant when there are more than one missing lymph node station according to the guidelines of The Japanese Research Society for Gastric Cancer (JRSGC) lymph node grouping |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| operating time | operation day | From skin incision to wound closure |
| time to first flatus | postoperative 1 week | the day when a patient relieve gastrointestinal gas |
| number of retrieved lymph nodes | postoperative 1 week | — |
| number of retrieved lymph nodes at each stations | postoperative 1 week | — |
| Postoperative surgical complications | postoperative 1 day, 1 week, 1 months, 3 months, 6 months, 12 months | Major and minor, and short term and long term complications related with surgery will be monitored and recorded according to classification of Accordion Severity Classification of Postoperative Complications; Expanded Classification. |
| distal resection margin, | postoperative 1 week | — |
| unanimity rate of 3 randomly assigned laparoscopic gastric cancer surgeons | postoperative 3 months | Three randomly assigned laparoscopic gastric cancer surgeons would evaluate the uneditted video and photoes and validate the lymph node dissection according to each stations.When the three surgeons agree that D2 lymph node dissection was performed, it is considered as unanimity. |
| 3-year disease free survival | postoperative 3 years | — |
| proximal resection margin | postoperative 1 week | — |
Countries
South Korea
Outcome results
None listed