D2 Versus D1 Gastrectomy of Operable Gastric Cancer

Completed

• Conditions: Gastric Cancer
• Interventions: Procedure: Radical gastrectomy with D1 lymphadenectomy; Procedure: Radical gastrectomy with D2 lymphadenectomy

• Registration Number: NCT04429841
• Lead Sponsor: Alexandria University

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2016-01
• Status Verified: 2020-06
• Study Completion: 2020-06
• Study First Submitted: 2020-06-10
• Study First Submitted QC: 2020-06-10
• Last Update Submitted: 2020-06-10
• Study First Posted: 2020-06-12
• Last Update Posted: 2020-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
D1 Gastrectomy	Radical gastrectomy with D1 lymphadenectomy	Patients are managed by radical gastrectomy with D1 lymphadenectomy
D2 Gastrectomy	Radical gastrectomy with D2 lymphadenectomy	Patients are managed by radical gastrectomy with D2 lymphadenectomy

Primary Outcome Measures

Name	Time	Method
Operative mortality rate	30 days after surgery	Frequency of early postoperative mortality
Postoperative morbidity rate	30 days after surgery	Frequency of early postoperative complications

Secondary Outcome Measures

Name	Time	Method
5 years Recurrence rate	5 years after surgery	Frequency of tumor recurrence within 5 years after curative surgery
5 years Cancer specific mortality rate	5 years after surgery	Frequency of Cancer specific mortality within 5 years after curative surgery
5 years Disease free survival rate	5 years after surgery	Percentage of patients survived for 5 years after surgery without tumor recurrence
5 years Overall survival rate	5 years after surgery	Percentage of patients survived for 5 years after surgery with/without tumor recurrence