Diaphragm Kinetics Following Hepatic Resection

NCT04889235 | Unknown

• 1 other identifier: EK 309-18
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diaphragm Kinetics; Sarcopenia; Muscle Wasting; Liver Resection

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (7)

• Diaphragm kinetics

  30 days

• Diaphragm kinetics

  30 days

• Diaphragm kinetics

  30 days

• Diaphragm kinetics

  30 days

• Abdominal muscle kinetics

  30 days

Study Arms (2)

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)

Procedure: Major liver resection

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)

Procedure: Major liver resection

Interventions

Major liver resection PROCEDURE

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

No Sarcopenia; Sarcopenia

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

Uniklinik Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

RECRUITING

MeSH Terms

Conditions

Sarcopenia; Muscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Gregory van der Kroft, M.D.

CONTACT

+492418089501; gvanderkroft@ukaachen.de

Steven Olde Damink, Prof.

CONTACT

steven.oldedamink@maastrichtuniversity.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator. Drs.

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: May 17, 2021
• Study Start: April 1, 2020
• Primary Completion: May 1, 2022
• Study Completion: November 1, 2022
• Last Updated: May 17, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)