Gastric Cancer
Conditions
Keywords
Operable gastric cancer, D2 vs D1 lymphadenectomy, Surgical and Oncologic outcomes
Brief summary
Gastric carcinoma is the second most common cause of cancer-related deaths and its main treatment modality if potentially curable is surgery but the optimal surgical resection is controversial. The aim of the current study was to assess the outcomes of curative D2 compared to D1 gastrectomy of operable gastric carcinoma regarding postoperative morbidity and mortality, disease recurrence and survival rates.
Detailed description
80 consecutive patients with potentially operable gastric carcinoma were randomized via concealed envelopes into 2 groups (each included 40 patients), group I managed by radical gastrectomy with D1 lymphadenectomy while group II managed by radical gastrectomy with D2 lymphadenectomy . Both groups were compared regarding postoperative mortality, morbidities, tumor recurrence and 2 years survival rates.
Interventions
PROCEDURED2 lymphadenectomy
Radical gastrectomy with D2 lymphadenectomy
PROCEDURED1 lymphadenectomy
Radical gastrectomy with D1 lymphadenectomy
Sponsors
University of Alexandria
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Randomization by opaque sealed envelopes
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed gastric carcinoma * Potentially operable gastric carcinoma without evidence of distant metastasis
Exclusion criteria
* Complicated gastric cancer (obstructed or perforated) * Locally irresectable tumor * Previous or coexisting cancer * Prior gastric surgery or neoadjuvant chemotherapy * Contraindication for major surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative morbidity rate | 30 days after surgery | Frequency of early postoperative complications |
| Operative mortality rate | Within 30 days after surgery | Frequency of early postoperative mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 2 years Recurrence rate | 2 years after surgery | Frequency of tumor recurrence within 2 years after curative surgery |
| 2 years Cancer specific mortality rate | 2 years after surgery | Frequency of patients died because of gastric cancer within 2 years after curative surgery |
| 2 years Disease free survival rate | 2 years after surgery | Percentage of patients survived for 2 years without tumor recurrence |
| 2 years Overall survival rate | 2 years after surgery | Percentage of patients survived for 2 years with/without tumor recurrence |
Outcome results
None listed