Clinical trial NCT04889235: Diaphragm Kinetics Following Hepatic Resection
Official title: Diaphragm Kinetics Following Hepatic Resection, Comparison Between a Sarcopenic and Non-sarcopenic Cohort.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diaphragm Kinetics
Sarcopenia
Muscle Wasting
Liver Resection
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2021-05-17
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Diaphragm kinetics
timeFrame: Day 1
measure: Diaphragm kinetics
timeFrame: Day 1
measure: Diaphragm kinetics
timeFrame: Day 1
measure: Diaphragm kinetics
timeFrame: Day 1
measure: Abdominal muscle kinetics
timeFrame: Day 1
measure: Abdominal muscle kinetics
timeFrame: Day 1
measure: Abdominal muscle kinetics
timeFrame: Day 1
Secondary outcomes:
measure: Diaphragm kinetics
timeFrame: 30 days
measure: Diaphragm kinetics
timeFrame: 30 days
measure: Diaphragm kinetics
timeFrame: 30 days
measure: Diaphragm kinetics
timeFrame: 30 days
measure: Abdominal muscle kinetics
timeFrame: 30 days
measure: Abdominal muscle kinetics
timeFrame: 30 days
measure: Abdominal muscle kinetics
timeFrame: 30 days
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Uniklinik Aachen
state: NRW
Study officials:
References: