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临床试验/NCT07159711
NCT07159711招募中不适用

Evaluation of Seismocardiography (SCG) as a Tool for Assessing Fitness and Predicting Outcomes in Oesophageal Cancer Surgery

Guy's and St Thomas' NHS Foundation Trust4 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
164
试验地点
4
主要终点
Rate of pneumonia as defined by the Esophageal Complications Consensus Group criteria (ECCG).

研究概览

简要总结

Oesophageal cancer is a common cause of cancer death worldwide. Curative treatment involves chemotherapy and surgery but has significant risks. Therefore, patient selection and improving physical fitness to withstand such major treatment is important to reduce the risk of complications. Physical fitness is traditionally measured by a specialised exercise test called Cardiopulmonary exercise testing (CPET), which can take up to one hour and requires specialised staff and expensive equipment such as a graded exercise bike or treadmill. Seismofit is a small device (smaller than a smartphone) used to estimate fitness in patients in under three minutes while lying down at rest. It measures the vibrations generated by the heart and, together with patient height, weight, age, and gender, accurately estimates fitness using an algorithm developed in healthy patients. The device has never been tested in a large group of oesophageal cancer patients to see if it can be used to predict complications in patients undergoing cancer treatment.

In this study, patients undergoing Oesophageal cancer treatment with chemotherapy or chemoradiotherapy and surgery will have Seismofit measurements at various points during their treatment to see if we can predict complications and hospital stay. Secondly, this study will also evaluate the accuracy of Seismofit compared to the gold standard CPET results in cancer patients.

详细描述

Oesophageal cancer is the 8th most common cause of cancer and the 6th leading cause of cancer-related deaths worldwide(West et al., 2016; Liu et al., 2023). Surgery with curative intent has been associated with significant morbidity and mortality despite recent advancements in anaesthesia and surgical techniques(Wu et al., 2014). Good patient selection with optimisation of cardiorespiratory fitness (CRF) is essential to improve surgical outcomes(West et al., 2014; Ozova et al., 2022). This is particularly important given that most oesophageal cancer patients undergo neo-adjuvant treatment (e.g. chemotherapy), which is known to have a significant adverse effect on patient fitness before surgery (mean reduction of 12.1% in VO2Peak) (Jack et al., 2014). A lower baseline level of fitness has also been shown to be associated with morbidity and mortality in patients undergoing treatment with curative intent (Hennis et al., 2011; West et al., 2024). Prehabilitation is now considered the standard of care in oesophageal cancer surgery, with societal guidance recently recommending a baseline fitness assessment to tailor the intervention as well as a means of monitoring response (Walker et al., 2024).

Cardiopulmonary Exercise Testing (CPET) is considered the gold standard in measuring the CRF of an individual by obtaining the maximal volume of oxygen consumed (VO2Peak) in samples of expired gas during a graded effort cycle ergometer test (Krogh et al., 2020; Levett et al., 2018a). However, CPET is a resource-intensive, costly, time-consuming test (requiring up to 60 minutes) and creates a significant time burden on patients with already busy treatment schedules. In a UK survey of prehabilitation practice, 50% of Upper Gastrointestinal (UGI) units used CPET at baseline, with only 80% of these (40% total) using CPET for response assessment (Barman et al. 2024 in revision for publication Annals RCS Eng).

Seismofit® is a device that accurately estimates the VO2Peak using machine learning algorithms incorporating seismocardiography (SCG) and patient parameters such as height, weight, age, and gender. SCG is a process by which vibrations generated by the heart during its regular physiological cycles are characterised and mapped for changes in morphology, frequency, intensity and character(Sørensen et al., 2018). Key advantages of Seismofit® include its inter-test reliability, rapid availability of results (i.e., estimation of fitness in under 3 minutes in an outpatient setting), and accurate estimation of fitness in a resting patient (Hansen et al., 2023a). The accuracy of Seismofit® in comparison to CPET-measured CRF has previously been demonstrated with a Mean Absolute Percentage Error (MAPE) of 12.3% in healthy adult populations(Hansen et al., 2023b). However, there is minimal data on cancer patients, and no studies have correlated VO2Peak generated by Seismofit® to clinical outcomes.

Given the potential benefits of Seismofit® over CPET, this study will investigate its validity in a clinical setting across four major Oesophageal cancer resection centres (Guy's and St Thomas NHS Foundation Trust (GSTT), University Hospitals Southampton (UHS), Royal Marsden NHS Foundation Trust (RM) and Royal Surrey NHS Foundation Trust (RS).

This will be the first study to evaluate the use of Seismofit® in a large volume of oesophageal cancer patients. With correlation to clinical outcomes, this study will serve as the basis for future research into the use of Seismofit® in a clinical setting.

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

入选标准

  • Age >=18
  • Diagnosis of Oesophageal cancer (T0-4 N0-3 M0, Oesophageal / Gastro-Oesophageal Junction (GOJ) type 1-2 adenocarcinoma
  • Patients being considered for curative treatment (i.e. due to undergo NAC and Oesophagectomy / Oesophago-Gastrectomy [open / MIO / hybrid / robotic])
  • Patients able to give informed consent

排除标准

  • Pregnant patients.
  • Patients under the age of
  • Patients undergoing primary Oesophagectomy +/- Oesophago-Gastrectomy with no neoadjuvant therapy.
  • Patients undergoing Neoadjuvant chemoradiotherapy.
  • Patient's being treated with curative intent for Oesophageal Squamous cell carcinoma
  • Patients that are deemed not fit or suitable for Oesophagogastric cancer resection as part of a Multi-Disciplinary Team meeting decision.
  • Patients with implanted devices such as pacemakers or cardioverter-defibrillators.

结局指标

主要结局

Rate of pneumonia as defined by the Esophageal Complications Consensus Group criteria (ECCG).

时间窗: 2 Years

This study will evaluate whether fitness and changes in the Seismofit estimated VO2Max through the treatment period will be able to predict increased rates of pneumonia.

Overall rate of complications as defined by the Clavien-Dindo classification

时间窗: 2 Years

This study will evaluate whether fitness and changes in the Seismofit estimated VO2Max through the treatment period will be able to predict increased overall complications as well overall major complications defined as Clavien-Dindo Classification of III and above.

Total hospital length of stay for patients being treated for Oesophageal cancer

时间窗: 2 Years

This study will evaluate whether fitness and changes in the Seismofit estimated VO2Max will be able to predict increased hospital length of stay.

次要结局

  • Seismofit® estimated VO2Peak reading accuracy compared to "gold standard" CPET measured VO2Peak.(2 Years)
  • To compare if Seismofit® is able to stratify patients into the lower quartiles of fitness accurately based on CPET measured fitness.(2 Years)
  • To investigate Seismofit® estimated fitness and Chemotherapy compliance & tolerability.(2 Years)
  • ITU length of stay (and re-admission)(2 Years)
  • Anastomotic leak rates(2 Years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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