Diaphragm Kinetics Following Hepatic Resection

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04889235
• Other study ID #: EK 309-18
• Status: Recruiting
• Start date: April 1, 2020
• Est. completion date: November 1, 2022

Study information

• Verified date: May 2021
• Source: RWTH Aachen University
• Contact: Gregory van der Kroft, M.D.
• Phone: +492418089501
• Email: gvanderkroft[@]ukaachen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: November 1, 2022
• Est. primary completion date: May 1, 2022
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Resection
• Muscle Wasting
• Muscular Atrophy
• Sarcopenia

Intervention

Procedure:
• Major liver resection
All patients undergo Major hepatic resection, differences between sarcopenia and no-sarcopenia groups will be observed

Locations

Country	Name	City	State
Germany	Uniklinik Aachen	Aachen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diaphragm kinetics	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
Primary	Diaphragm kinetics	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
Primary	Diaphragm kinetics	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
Primary	Diaphragm kinetics	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
Primary	Abdominal muscle kinetics	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
Primary	Abdominal muscle kinetics	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
Primary	Abdominal muscle kinetics	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
Secondary	Diaphragm kinetics	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
Secondary	Diaphragm kinetics	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
Secondary	Diaphragm kinetics	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
Secondary	Diaphragm kinetics	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
Secondary	Abdominal muscle kinetics	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
Secondary	Abdominal muscle kinetics	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
Secondary	Abdominal muscle kinetics	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