Набор скоро начнётся NCT06999512

Impact of Comprehensive Geriatric Management on Morbidity and Quality of Life in Elderly Patients Undergoing Major Hepatectomy and Pancreaticoduodenectomy for Cancer

Фаза II / Фаза III С лечением Hepatobiliary Cancer Pancreatic Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Comprehensive Geriatric Assessment.
Кому может быть актуально: Состояния в реестре: Hepatobiliary Cancer, Pancreatic Cancer. Базовые параметры: от 70 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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.

Обзор

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.

Вмешательства

Процедура Comprehensive Geriatric Assessment
CGA: * Preoperative geriatric consultation * Perioperative tailored intervention if needed * Postoperative geriatric follow-up * M3 geriatric consultation

Первичные конечные точки

Comprehensive Complex Index (CCI) value [Срок оценки: 90 days after surgery]

Вторичные конечные точки (12)

Quality of life scale: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) [Срок оценки: at 3, 6 and 12 months post surgery]
Quality of life scale EQ-5D-5L [Срок оценки: at 3, 6 and 12 months post surgery]
Quality of life scale ELD14 [Срок оценки: at 3, 6 and 12 months post surgery]
Discharge status [Срок оценки: 90 days after surgery]
All-cause mortality at 90 days after surgery [Срок оценки: at 3 months post surgery]
complication occurence and classification [Срок оценки: at 3 months post surgery]
Post-operative hospital length of stay (in days) [Срок оценки: through study completion (an average of 5.5 years)]
Post-operative ICU length of stay (in days) [Срок оценки: through study completion (an average of 5.5 years)]
Loss of independence at 3 months after surgery [Срок оценки: 90 days after surgery]
Time (in days) between the date of randomization and the date of surgery [Срок оценки: from randomization to surgery, a maximum of 1 month]
Overall survival [Срок оценки: at 12 months post surgery]
time from surgery to cancer recurrence or death from any cause [Срок оценки: through study completion (an average of 5.5 years)]

Критерии участия

Критерии включения

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)