Assessment of Measures of Sarcopenia and Whole Body Physiology in Cancer Patients and Their Relationship to Surgical Outcome and Survival
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 639
- 试验地点
- 1
- 主要终点
- Skeletal muscle radiation attenuation at L3
研究概览
简要总结
Primary Aim:
To establish a reliable relationship between oxygen uptake (VO2) at estimated lactate threshold (AT) and CT-derived body composition measurments (e.g. muscle radiation attenuation), and to relate these to post-operative outcomes (i.e. post-operative complications or 1-year survival) in cohort of upper (UGI) and lower (LGI) gastrointestinal and hepatobiliary (HPB) cancer patients undergoing surgery +/- cancer therapies.
Rationale:Objectively measured reduction of muscle radiation attenuation (i.e. Computed Tomography (CT) measured indices of muscle wasting) coupled with reduced physical fitness (measured objectively using Cardiopulmonary Exercise Testing (CPET)) will result in worse post-operative surgical outcome and reduced survival.
Trial Design: Observational Sample size: See statistical analyses section for individual cohort power calculations Inclusion Criteria: Male or female patients, aged over 18 years old with UGI, LGI or HPB cancer undergoing surgery +/- cancer therapies; WHO performance status 0-2.
Exclusion Criteria: Patients will be excluded if they have surgery for benign disease, a diagnosis of inflammatory bowel disease, patients physically unable to perform a CPET on a cycle ergometer, patients having no surgery performed or interim emergency surgery, patients lacking complete in-hospital morbidity and survival data.
Primary Trial Endpoints: UGI patients - 2 year overall survival, LGI and HPB patients - post-operative complications (Calvien-Dindo and Composite Endpoint in pancreaticoduodenectomy)
详细描述
Study overview and background
We hypothesise that an objectively measured reduction in muscle radiation attenuation (i.e. Computed Tomography (CT) measured indices of muscle wasting and/or sarcopenia) coupled with reduced physical fitness (measured objectively using Cardiopulmonary Exercise Testing (CPET)) will result in worse post-operative surgical outcome and reduced survival in patients going straight to surgery or having cancer therapies.
An analyses of prospectively collected clinical data from routine clinical practice in a cohort of upper and lower gastrointestinal and hepatobiliary (liver, pancreas and biliary tree) cancer patients will be undertaken. These patients may undergo neoadjuvant (before surgery) cancer therapies before undergoing surgery.
We aim to interrogate prospectively collected objectively measures of radiological markers of muscle wasting and body composition, as well as objectively measured markers of physical fitness in 3 cohorts: upper and lower gastrointestinal and hepatobiliary (liver, pancreas and biliary tree) cancer patients and to explore if body composition is related with physical fitness. In addition, body composition and physical fitness will be related to post-operative outcomes and survival. These data will be readily available as they are collected as part of routine clinical care at University Hospital Southampton NHS Foundation Trust. Our hospital performs a large number of major cancer operations in these 3 cancer patient groups. These patients already undergo accurate radiological cancer staging and sometimes re-staging (after cancer therapies) and also a CPET as part of their pre-operative pathway. As part of their enhanced recovery pathway, which is now well embedded into routine clinical care, post-operative surgical outcomes, cancer outcomes and survival are routinely collected.
METHODOLOGY
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients
- •aged over 18 years old
- •undergoing surgery and/or cancer therapies
- •WHO performance status 0-2.
排除标准
- •benign disease
- •a diagnosis of inflammatory bowel disease
- •patients physically unable to perform a CPET on a cycle ergometer
- •patients having no surgery performed or interim emergency surgery
- •patients lacking complete in-hospital morbidity and survival data.
结局指标
主要结局
Skeletal muscle radiation attenuation at L3
时间窗: up to 4 week before surgery
muscle radiation attenuation using CT L3 image slice using Slico-matic software
次要结局
- Survival(at 1 year after surgery)
- oxygen uptake at lactate threshold(up to 4 weeks before surgery)
- Surgical morbidity(throughout study completion whilst patient is in hospital, up to 6 months)