Diaphragm Kinetics Following Hepatic Resection

NCT ID: NCT04889235

Last Updated: 2021-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 44 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2022-11-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

Major liver resection

Intervention Type: PROCEDURE

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)

Major liver resection

Intervention Type: PROCEDURE

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

Interventions

Major liver resection

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Gregory van der Kroft

Principal investigator. Drs.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Uniklinik Aachen

Aachen, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Gregory van der Kroft, M.D.

Role: CONTACT

gvanderkroft@ukaachen.de

+492418089501

Steven Olde Damink, Prof.

Role: CONTACT

steven.oldedamink@maastrichtuniversity.nl

Facility Contacts

Gregory van der Kroft, M.D.

Role: primary

gvanderkroft@ukaachen.de

Other Identifiers

EK 309-18

Identifier Type: -

Identifier Source: org_study_id