D2 Versus D1 Gastrectomy of Operable Gastric Cancer

Study Overview
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Brief Summary
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Surgery is the mainstay treatment of operable gastric carcinoma but the optimal extent of lymph node (LN) dissection is controversial. The aim of this observational study is to assess the outcomes after curative D2 compared to D1 gastrectomy of operable gastric carcinoma regarding operative and long term oncological outcomes.

Detailed Description
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This observational study included 80 consecutive patients presented by operable gastric cancer treated by D2 gastrectomy at Alexandria University hospital between January 2010 and January 2016, (Group I). Another 68 consecutive patients presented by operable gastric cancer treated by D1 gastrectomy earlier during the same period were included as a control (Group II). All patients had undergone preoperative gastroscopy and biopsy, chest and abdomen computed tomography (CT). All surgeries were performed by surgeons experienced in both D1 and D2 dissection and a standardized protocol for D1 and D2 gastrectomy was followed in all patients. The type of gastrectomy (distal or total) was done according to the site of the tumor; distal gastrectomy was done if there is a free safety margin of 4 cm beyond the proximal resection line otherwise total gastrectomy was done. Resection of the spleen and/or pancreatic tail were done if directly invaded by the primary tumor or metastatic LN. Patients with p T2 or greater, or with positive LN received adjuvant chemotherapy. Follow up was done as outpatient visits for average 5 years. Both groups were compared regarding postoperative morbidity and mortality, disease recurrence and survival rates.

Official Title
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Operative and Long Term Oncological Outcomes After D2 Versus D1 Gastrectomy of Operable Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: Radical gastrectomy with D1 lymphadenectomy
* Procedure: Radical gastrectomy with D2 lymphadenectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients younger than 80 years with a histologically confirmed operable adenocarcinoma of the stomach with complete follow up after surgery for average 5 years Exclusion Criteria: Complicated gastric cancer (obstructed or perforated) Irresectable or metastatic disease Previous or coexisting cancer Prior gastric surgery.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| D1 Gastrectomy<br>Patients are managed by radical gastrectomy with D1 lymphadenectomy | Procedure: Radical gastrectomy with D1 lymphadenectomy<br> <br> |
| D2 Gastrectomy<br>Patients are managed by radical gastrectomy with D2 lymphadenectomy | Procedure: Radical gastrectomy with D2 lymphadenectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative morbidity rate | Frequency of early postoperative complications | 30 days after surgery | 
| Operative mortality rate | Frequency of early postoperative mortality | 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5 years Recurrence rate | Frequency of tumor recurrence within 5 years after curative surgery | 5 years after surgery | 
| 5 years Cancer specific mortality rate | Frequency of Cancer specific mortality within 5 years after curative surgery | 5 years after surgery | 
| 5 years Disease free survival rate | Percentage of patients survived for 5 years after surgery without tumor recurrence | 5 years after surgery | 
| 5 years Overall survival rate | Percentage of patients survived for 5 years after surgery with/without tumor recurrence | 5 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Operable Gastric Cancer, D2 Gastrectomy, D1 Gastrectomy, Operative Mortality & Morbidity, Oncological Outcomes