Gastric cancer Cancer Malignant neoplasm of stomach
Conditions
Interventions
The study was performed according to the rules of the JRGC as regards the extent of stomach removal and the technique of lymph-node dissection (D1 and D2 procedures) and to the Japanese Classification
Sponsors
Health Research Aimed at the Regione Piemonte (Ricerca Sanitaria Finalizzata della Regione Piemonte) (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histology proven and potentially curable gastric adenocarcinoma, not requiring emergency surgery 2. Aged younger than 80 years, either sex 3. In adequate physical condition without serious co-morbid cardio-respiratory diseases which could preclude a safe D2 procedure 4. Have not undergone previous gastric surgery 5. Does not harbor a coexisting cancer
Exclusion criteria
Exclusion criteria: 1. Absence of macroscopic involvement of liver and peritoneum (HO, PO) 2. Absence of macroscopic involvement of adjacent organs (T less than 4) 3. Absence of macroscopic massive involvement of N2 nodes (enlarged nodes at coeliac area) 4. Absence of malignant cells in para-aortic nodes (16B1) at biopsy and frozen section 5. Absence of malignant cells in peritoneal washing fluid, during intra-operative fresh examination 6. Absence of macroscopic residual tumour (RO) 7. No involvement of the oesophagus, cardia or duodenum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival: follow-up for mortality analysed with the Kaplan-Mayer risk assessment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Complications (general and surgical) and reoperations assessed post-operatively 2. Hospital mortality, defined as death occurring within 30 days from the procedure or during patient's hospital stay Follow-up was done at regular intervals (4 months) and follow-up data were sent every 6 months to the Reference Centre where all data were collected. | — |
Countries
Italy
Outcome results
None listed