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临床试验/NCT04429841
NCT04429841已完成不适用

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

Alexandria University0 个研究点目标入组 148 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
148
主要终点
Postoperative morbidity rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients younger than 80 years with a histologically confirmed operable adenocarcinoma of the stomach with complete follow up after surgery for average 5 years

排除标准

  • Complicated gastric cancer (obstructed or perforated)
  • Irresectable or metastatic disease
  • Previous or coexisting cancer
  • Prior gastric surgery.

结局指标

主要结局

Postoperative morbidity rate

时间窗: 30 days after surgery

Frequency of early postoperative complications

Operative mortality rate

时间窗: 30 days after surgery

Frequency of early postoperative mortality

次要结局

  • 5 years Recurrence rate(5 years after surgery)
  • 5 years Cancer specific mortality rate(5 years after surgery)
  • 5 years Disease free survival rate(5 years after surgery)
  • 5 years Overall survival rate(5 years after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed El Messiry

Assistant professor of Surgery

Alexandria University

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