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临床试验/NCT06079229
NCT06079229已完成不适用

Pilot Study of Geriatric Parameters and Quality of Life in Patients Over 70 Years Old Undergoing Pancreatic Cancer Surgery

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2023年11月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
Evolution in the ADL questionnaire score between pre-operative and post-operative 3 to 30 months after surgery.

研究概览

简要总结

Pancreatic cancer mainly affects the elderly, with over 85% of patients diagnosed after the age of 60 and over half after the age of 70. In France, the incidence of pancreatic cancer is currently around 14,000 new cases per year, making it the fourth leading cause of cancer death in women and the fifth in men.

Surgery is currently the only curative option available to patients, but it is not an option for many patients who already have metastatic or locally advanced cancer at the time of diagnosis. The main studies carried out on this type of intervention in the elderly focus on the surgical aspect, and the tolerability of such surgery is not well studied.

The aim of this study is to describe the impact of pancreatic surgery on the independence in daily activities and quality of life of patients aged over 70 with pancreatic cancer. These patients underwent surgery at Édouard Herriot Hospital (Hospices Civils de Lyon) since July 2021, and the assessment will be conducted through telephone questionnaires.

It is hypothesised that these patients will be able to maintain their independence in terms of daily activities.

研究设计

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

入排标准

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

入选标准

  • Subjects with histologically proven pancreatic cancer (all types) on biopsy or surgical specimen
  • Operated on for this cancer (by cephalic duodenopancreatectomy or left pancreatectomy) at the Édouard Herriot Hospital since July 2021
  • 70 years of age or older at the time of surgery.

排除标准

  • Patients who have expressed their opposition to the study
  • Patients under curatorship, guardianship or legal protection
  • Patient unable to express non-opposition
  • Patient unreachable after 4 attempted calls over 3 consecutive weeks
  • Patient deceased at the time of the telephone call
  • Persons deprived of their liberty by a judicial or administrative decision
  • Persons under compulsory psychiatric care

结局指标

主要结局

Evolution in the ADL questionnaire score between pre-operative and post-operative 3 to 30 months after surgery.

时间窗: Between 3 months and 30 months after surgery.

The ADL score (Activities of Daily Living) is designed to assess independence for activities of daily living. It is scored from 0 to 6, with 6 representing maximum independence for activities of daily living (washing, eating, dressing, etc.) and 0 a complete lack of independence. The significance of the difference in the ADL score before and after surgery will be tested using the Wilcoxon test. ADL will therefore be measured at 3 months after surgery at the earliest and at 30 months at the latest, at the time of the telephone call with the patient. The pre-operative value is recorded in the patient's file, measured a few weeks before surgery.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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