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Diaphragm Kinetics Following Hepatic Resection

11 мая 2021 г. обновлено: Gregory van der Kroft, RWTH Aachen University

Diaphragm Kinetics Following Hepatic Resection, Comparison Between a Sarcopenic and Non-sarcopenic Cohort.

Sarcopenia is associated with reduced pulmonary function in healthy adults, as well as with increased risk of pneumonia following abdominal surgery. Consequentially, postoperative pneumonia prolongs hospital admission, and increases in-hospital mortality following a range of surgical interventions. Little is known about the function of the diaphragm in the context of sarcopenia and wasting disorders or how its function is influenced by abdominal surgery. Liver surgery induces reactive pleural effusion in most patients, compromising post-operative pulmonary function.

Hypotheses:

  • Both major hepatic resection and sarcopenia have a measurable impact on diaphragm function.
  • Sarcopenia is associated with reduced preoperative diaphragm function, and that patients with reduced preoperative diaphragm function show a greater decline and reduced recovery of diaphragm function following major hepatic resection.

Goals:

The primary goal of this study is to evaluate whether sarcopenic patients have a reduced diaphragm function prior to major liver resection compared to non-sarcopenic patients, and to evaluate whether sarcopenic patients show a greater reduction in respiratory muscle function following major liver resection when compared to non-sarcopenic patients.

Methods and analysis:

Trans-costal B-mode, M-mode ultrasound and speckle tracking imaging will be used to assess diaphragm function perioperatively in patients undergoing major hepatic resection starting one day prior to surgery and up to thirty days after surgery. In addition, rectus abdominis and quadriceps femoris muscles thickness will be measured using ultrasound to measure sarcopenia, and pulmonary function will be measured using a hand-held bedside spirometer. Muscle mass will be determined preoperatively using CT-muscle volumetry of abdominal muscle and adipose tissue at the third lumbar vertebra level (L3). Muscle function will be assessed using handgrip strength and physical condition will be measured with a short physical performance battery (SPPB). A rectus abdominis muscle biopsy will be taken intraoperatively to measure proteolytic and mitochondrial activity as well as inflammation and redox status. Systemic inflammation and sarcopenia biomarkers will be assessed in serum acquired perioperatively.

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Тип исследования

Наблюдательный

Регистрация (Ожидаемый)

44

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Gregory van der Kroft, M.D.
  • Номер телефона: +492418089501
  • Электронная почта: gvanderkroft@ukaachen.de

Учебное резервное копирование контактов

Места учебы

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 85 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Н/Д

Полы, имеющие право на обучение

Все

Метод выборки

Невероятностная выборка

Исследуемая популяция

This study will entail a prospective observational single center study, analyzing 44 consecutive patients undergoing major liver resection, 22 patients will be sarcopenic, 22 will be non-sarcopenic

Описание

Inclusion Criteria:

  • Patients between 18- and 80 years old
  • Patients undergoing elective Major hepatic resection for the treatment of malignant disease.
  • Patients with all tumor Stages (TNM classification).
  • Only patients undergoing Major hepatic resection.

Exclusion Criteria:

  • American Anesthesiology Association (ASA)-classification IV or higher
  • Liver cirrhosis Child grade B or higher
  • End stage renal disease requiring dialysis
  • Severe heart disease New York Heart Association class IV

  • Pulmonary condition:

    • Chronic obstructive pulmonary disease (COPD)
    • Asthma
    • History of pulmonary surgery
    • History of pulmonary embolism
    • Smoking
    • Pleural effusion occupying more than 1/3 of the pleural space
  • Neurological disorders leading to paraparesis of the upper or lower limbs
  • Known muscular dystrophic disorders

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Когорты и вмешательства

Группа / когорта
Вмешательство/лечение
Sarcopenia
Sarcopenia will be defined as either low estimated muscle mass measured by CT-muscle volumetry or reduced muscle function measured by handgrip strength, or reduced physical condition as defined by the European Working Group on Sarcopenia in Older People (EWGSOP)
Процедура: Major liver resection
All patients undergo Major hepatic resection, differences between sarcopenia and no-sarcopenia groups will be observed
No Sarcopenia
Sarcopenia will be defined as either low estimated muscle mass measured by CT-muscle volumetry or reduced muscle function measured by handgrip strength, or reduced physical condition as defined by the European Working Group on Sarcopenia in Older People (EWGSOP)
Процедура: Major liver resection
All patients undergo Major hepatic resection, differences between sarcopenia and no-sarcopenia groups will be observed

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Diaphragm kinetics
Временное ограничение: Day 1

Comparing diaphragm kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound.

Diaphragm muscle kinetics will be evaluated using the following outcome value.

-Deformation%

Mean values and standard deviations of individual values describing diaphragm kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)
Day 1
Diaphragm kinetics
Временное ограничение: Day 1

Comparing diaphragm kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound.

Diaphragm muscle kinetics will be evaluated using the following value.

-Deformation velocity (in cm/second)

Mean values and standard deviations of individual values describing diaphragm kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)
Day 1
Diaphragm kinetics
Временное ограничение: Day 1

Comparing diaphragm kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound.

Diaphragm muscle kinetics will be evaluated using the following value.

-Fractional thickening (thickening coefficient)

Mean values and standard deviations of individual values describing diaphragm kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)
Day 1
Diaphragm kinetics
Временное ограничение: Day 1

Comparing diaphragm and abdominal muscle kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound.

Diaphragm muscle kinetics will be evaluated using the following value.

-Range of DIA (in cm)

Mean values and standard deviations of individual values describing diaphragm kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)
Day 1
Abdominal muscle kinetics
Временное ограничение: Day 1

Primary outcome:

Comparing abdominal muscle kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound.

Abdominal muscle kinetics will be evaluated using the following value.

-Thickness (in cm)

Mean values and standard deviations of individual values describing abdominal muscle kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)
Day 1
Abdominal muscle kinetics
Временное ограничение: Day 1

Primary outcome:

Comparing abdominal muscle kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound.

Abdominal muscle kinetics will be evaluated using the following value.

-Deformation%

Mean values and standard deviations of individual values describing abdominal muscle kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)
Day 1
Abdominal muscle kinetics
Временное ограничение: Day 1

Primary outcome:

Comparing abdominal muscle kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound.

Abdominal muscle kinetics will be evaluated using the following value.

-Deformation velocity (in cm/second)

Mean values and standard deviations of individual values describing abdominal muscle kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)
Day 1

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Diaphragm kinetics
Временное ограничение: 30 days

Evaluating longitudinal changes in diaphragm kinetics in the postoperative phase across sarcopenic and non-sarcopenic groups following elective major hepatic resection using ST ultrasound.

Diaphragm muscle kinetics will be evaluated using the following value.

-Deformation%

Differences in mean values and standard deviations of individual values describing diaphragm muscle kinetics will be compared between sarcopenic and non-sarcopenic groups. Changes in diaphragm kinetics will be defined as changes from baseline values (primary outcome).
30 days
Diaphragm kinetics
Временное ограничение: 30 days

Evaluating longitudinal changes in diaphragm kinetics in the postoperative phase across sarcopenic and non-sarcopenic groups following elective major hepatic resection using ST ultrasound.

Diaphragm muscle kinetics will be evaluated using the following value.

-Deformation velocity (in cm/second)

Differences in mean values and standard deviations of individual values describing diaphragm muscle kinetics will be compared between sarcopenic and non-sarcopenic groups. Changes in diaphragm kinetics will be defined as changes from baseline values (primary outcome).
30 days
Diaphragm kinetics
Временное ограничение: 30 days

Evaluating longitudinal changes in diaphragm kinetics in the postoperative phase across sarcopenic and non-sarcopenic groups following elective major hepatic resection using ST ultrasound.

Diaphragm muscle kinetics will be evaluated using the following value.

-Fractional thickening (thickening coefficient)

Differences in mean values and standard deviations of individual values describing diaphragm muscle kinetics will be compared between sarcopenic and non-sarcopenic groups. Changes in diaphragm kinetics will be defined as changes from baseline values (primary outcome).
30 days
Diaphragm kinetics
Временное ограничение: 30 days

Evaluating longitudinal changes in diaphragm kinetics in the postoperative phase across sarcopenic and non-sarcopenic groups following elective major hepatic resection using ST ultrasound.

Diaphragm muscle kinetics will be evaluated using the following value.

-Range of DIA (in cm)

Differences in mean values and standard deviations of individual values describing diaphragm muscle kinetics will be compared between sarcopenic and non-sarcopenic groups. Changes in diaphragm kinetics will be defined as changes from baseline values (primary outcome).
30 days
Abdominal muscle kinetics
Временное ограничение: 30 days

Evaluating longitudinal changes in abdominal muscle kinetics in the postoperative phase across sarcopenic and non-sarcopenic groups following elective major hepatic resection using ST ultrasound.

Abdominal muscle kinetics will be evaluated using the following value.

-Thickness (in cm)

Differences in mean values and standard deviations of individual values describing abdominal muscle kinetics will be compared between sarcopenic and non-sarcopenic groups. Changes in diaphragm kinetics will be defined as changes from baseline values (primary outcome).
30 days
Abdominal muscle kinetics
Временное ограничение: 30 days

Evaluating longitudinal changes in abdominal muscle kinetics in the postoperative phase across sarcopenic and non-sarcopenic groups following elective major hepatic resection using ST ultrasound.

Abdominal muscle kinetics will be evaluated using the following value.

-Deformation%

Differences in mean values and standard deviations of individual values describing abdominal muscle kinetics will be compared between sarcopenic and non-sarcopenic groups. Changes in diaphragm kinetics will be defined as changes from baseline values (primary outcome).
30 days
Abdominal muscle kinetics
Временное ограничение: 30 days

Evaluating longitudinal changes in abdominal muscle kinetics in the postoperative phase across sarcopenic and non-sarcopenic groups following elective major hepatic resection using ST ultrasound.

Abdominal muscle kinetics will be evaluated using the following value.

-Deformation velocity (in cm/second)

Differences in mean values and standard deviations of individual values describing abdominal muscle kinetics will be compared between sarcopenic and non-sarcopenic groups. Changes in diaphragm kinetics will be defined as changes from baseline values (primary outcome).
30 days

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

RWTH Aachen University

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

1 апреля 2020 г.

Первичное завершение (Ожидаемый)

1 мая 2022 г.

Завершение исследования (Ожидаемый)

1 ноября 2022 г.

Даты регистрации исследования

Первый отправленный

21 октября 2020 г.

Впервые представлено, что соответствует критериям контроля качества

11 мая 2021 г.

Первый опубликованный (Действительный)

17 мая 2021 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

17 мая 2021 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

11 мая 2021 г.

Последняя проверка

1 мая 2021 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • EK 309-18

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования Major liver resection

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