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UnknownNCT04889235

Diaphragm Kinetics Following Hepatic Resection

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

Status
Unknown
Phase
Study type
Observational
Enrollment
44 (estimated)
Sponsor
RWTH Aachen University · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers

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

Interventions

TypeNameDescription
PROCEDUREMajor liver resectionAll patients undergo Major hepatic resection, differences between sarcopenia and no-sarcopenia groups will be observed

Timeline

Start date
2020-04-01
Primary completion
2022-05-01
Completion
2022-11-01
First posted
2021-05-17
Last updated
2021-05-17

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT04889235. Inclusion in this directory is not an endorsement.