Curative D2 vs D1 Lymphadenectomy in Operable Gastric Carcinoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Surgical and Oncologic Outcomes After Curative D2 vs D1 Gastrectomy in Operable Gastric Carcinoma, A Randomized Controlled Study in Egyptian Population

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: D1 lymphadenectomy
* Procedure: D2 lymphadenectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: D1 lymphadenectomy<br>Operable gastric cancer was treated by radical gastrectomy and limited D1 lymphadenectomy | Procedure: D1 lymphadenectomy<br>* Radical gastrectomy with D1 lymphadenectomy<br>|
| Active Comparator: D2 lymphadenectomy<br>Operable gastric cancer was treated by radical gastrectomy and extended D2 lymphadenectomy | Procedure: D2 lymphadenectomy<br>* Radical gastrectomy with D2 lymphadenectomy<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 | Within 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2 years Recurrence rate | Frequency of tumor recurrence within 2 years after curative surgery | 2 years after surgery | 
| 2 years Cancer specific mortality rate | Frequency of patients died because of gastric cancer within 2 years after curative surgery | 2 years after surgery | 
| 2 years Disease free survival rate | Percentage of patients survived for 2 years without tumor recurrence | 2 years after surgery | 
| 2 years Overall survival rate | Percentage of patients survived for 2 years with/without tumor recurrence | 2 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 vs D1 lymphadenectomy, Surgical and Oncologic outcomes