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Diaphragm Kinetics Following Hepatic Resection

11. května 2021 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Typ studie

Pozorovací

Zápis (Očekávaný)

44

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 85 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

N/A

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
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)
Postup: 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)
Postup: Major liver resection
All patients undergo Major hepatic resection, differences between sarcopenia and no-sarcopenia groups will be observed

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Diaphragm kinetics
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Diaphragm kinetics
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

RWTH Aachen University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. dubna 2020

Primární dokončení (Očekávaný)

1. května 2022

Dokončení studie (Očekávaný)

1. listopadu 2022

Termíny zápisu do studia

První předloženo

21. října 2020

První předloženo, které splnilo kritéria kontroly kvality

11. května 2021

První zveřejněno (Aktuální)

17. května 2021

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

17. května 2021

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

11. května 2021

Naposledy ověřeno

1. května 2021

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • EK 309-18

Plán pro data jednotlivých účastníků (IPD)

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Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

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Studuje produkt zařízení regulovaný americkým úřadem FDA

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