Impact of Comprehensive Geriatric Management on Morbidity and Quality of Life in Elderly Patients Undergoing Major Hepatectomy and Pancreaticoduodenectomy for Cancer. A Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 526
- 试验地点
- 12
- 主要终点
- Comprehensive Complex Index (CCI) value
研究概览
简要总结
The worldwide incidence of hepatobiliary and pancreatic (HPB) cancers is dramatically increasing especially for pancreatic cancer. Increasing age is associated with increased cancer risk. In North America and Europe, most people who are diagnosed with cancer every year are aged 65 years or older. Hepatectomy for hepatocellular carcinoma, intra hepatic and hilar cholangiocarcinoma, gallbladder cancer and hepatic metastases from colorectal cancer allows better survival compared to other treatments. Similarly, pancreaticoduodenectomy (PD) is the standard of care in patients with distal cholangiocarcinoma and patients with resectable pancreatic adenocarcinoma located in the head of the pancreas. This results in an increasing number of elderly patients being evaluated for hepatic and pancreatic surgery. Major hepatectomy and PD are amongst the most invasive and complex procedures in general surgery with high rates of morbidity as well as negative impact on quality of life. Many studies have reported poor post-surgical outcomes in the elderly patients, especially related to co-morbidities that characterizes this population such as, polypharmacy, cognitive decline, depression and malnutrition. The age in elderly cancer patient is not just a number. The management of these patients should not be limited to oncological care, but it should be extended to different clinical domains including physical, cognitive, psychological, socioeconomic and environmental aspects. In this population, the risk of adverse postoperative outcomes is not adequately described by routine format of current preoperative evaluation, such as age, comorbidities and other traditional tests. Furthermore, the Comprehensive Geriatric Assessment (CGA) is scarcely considered. The aim of CGA is to identify current health problems and to guide interventions thus reducing adverse outcomes and optimizing the functional status of older adults. Several trials have indeed shown that CGA and perioperative tailored interventions reduce morbidity and improve patient survival in other surgical disciplines. Similar data is lacking in both hepatic and pancreatic surgery.
The hypothesis is that CGA with perioperative tailored interventions could reduce postoperative morbidity in elderly patients after major hepatectomy and pancreaticoduodenectomy for cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 70 years, with histologically proven or clinical diagnosis of HPB cancer among the following:
- •hepatocellular carcinoma
- •intra-hepatic and peri-hilar cholangiocarcinoma
- •gallbladder cancer
- •peri-ampullary malignant tumors
- •pancreatic adenocarcinoma
- •colorectal liver metastases
- •Needing one of the following procedures:
- •Pancreaticoduodenectomy
- •Major Hepatectomy (≥ 3 hepatic segments)
排除标准
- •Patients who have no access to the French health system.
- •Patient unable to sign informed consent.
- •Patients included in a double-blind randomized trial
- •Patients legally protected
研究组 & 干预措施
Control group
standard care follow up for the patient: Routine preoperative workup, routine postoperative follow-up
Interventional group
standard care follow up for the patient: Routine preoperative workup, routine postoperative follow-up with Perioperative geriatric management: CGA, preoperative geriatric consultation, perioperative tailored intervention, postoperative geriatric follow-up
干预措施: Comprehensive Geriatric Assessment (Procedure)
结局指标
主要结局
Comprehensive Complex Index (CCI) value
时间窗: 90 days after surgery
Comparison of the 90-day postoperative morbidity between patients in the interventional arm (receiving preoperative CGA and perioperative tailored geriatric interventions) and those in the control arm (receiving standard of care). CCI is based on the Clavien-Dindo classification, and takes into account all cumulative complications and receives values between 0 (no complication) and 100 (death).
次要结局
- Loss of independence at 3 months after surgery(90 days after surgery)
- Overall survival(at 12 months post surgery)
- Quality of life scale: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)(at 3, 6 and 12 months post surgery)
- Quality of life scale EQ-5D-5L(at 3, 6 and 12 months post surgery)
- Quality of life scale ELD14(at 3, 6 and 12 months post surgery)
- Discharge status(90 days after surgery)
- All-cause mortality at 90 days after surgery(at 3 months post surgery)
- complication occurence and classification(at 3 months post surgery)
- Post-operative hospital length of stay (in days)(through study completion (an average of 5.5 years))
- Post-operative ICU length of stay (in days)(through study completion (an average of 5.5 years))
- Time (in days) between the date of randomization and the date of surgery(from randomization to surgery, a maximum of 1 month)
- time from surgery to cancer recurrence or death from any cause(through study completion (an average of 5.5 years))
- Percentage of patients that completed the geriatric intervention(through study completion (an average of 5.5 years))
- Percentage of patients contraindicated to surgery after CGA(through study completion (an average of 5.5 years))
- Time (in days) between the dates of randomization and preoperative geriatric consultation(through study completion (an average of 5.5 years))
- Time (in days) between the dates of preoperative geriatric consultation and onset of tailored interventions(through study completion (an average of 5.5 years))
- Time (in days) between the dates of preoperative geriatric consultation and surgery(through study completion (an average of 5.5 years))