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临床试验/NCT03909997
NCT03909997Unknown不适用

Severe Complications After Gastrectomy for Esophagogastric Junction and Gastric Cancer: Perioperative Results and Long Term Survival

Hospital Dr Sotero del Rio1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年4月5日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
Number of patients with severe 30-day or in-hospital morbidity

研究概览

简要总结

Gastrectomy is the main treatment for gastric and Siewert type II-III esophagogastric junction (EGJ) cancer. This surgery is associated with significant morbidity. The aim of the present study is to identify the predictors of postoperative morbidity and to evaluate long term survival according to complications. This is a retrospective cohort study.

详细描述

Gastrectomy is the main treatment for gastric and Siewert type II-III esophagogastric junction (EGJ) cancer. This surgery is associated with significant morbidity. The aim of the present study is to identify the predictors of postoperative morbidity and to evaluate long term survival according to complications.

This was a retrospective cohort study. The investigators included patients treated with gastrectomy for gastric or EGJ cancers at a single center. Severe morbidity was defined as Clavien-Dindo score ≥3.

The following factors are analyzed: age, sex, comorbidity, American Society of Anesthesiologists (ASA) physical status, tobacco and alcohol consumption, body mass index (BMI), hematocrit, serum albumin level, tumor location, the use of preoperative chemotherapy, laparoscopic or open surgery, total or subtotal gastrectomy, duodenal stump closure, multi-organ resection, lymphadenectomy, reconstruction method, T status, lymph node metastasis, and resection margin. The T stage was grouped by T1-T2 and T3-T4 for analysis. Patients will be followed for 5 years after surgery for survival analysis. A multivariate analysis is performed to identify predictors of overall and severe morbidity; and predictors of long-term survival.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • Patients treated with a gastrectomy for gastric cancer or esophagogastric cancer.
  • Confirmed adenocarcinoma histology.

排除标准

  • Histology different from adenocarcinoma.

结局指标

主要结局

Number of patients with severe 30-day or in-hospital morbidity

时间窗: Perioperative

Clavien 3 or higher complications

次要结局

  • Median and percentage of patients with long-term survival(5 years)

研究者

发起方
Hospital Dr Sotero del Rio
申办方类型
Other
责任方
Sponsor

研究点 (1)

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