A Biobank for Diaphragm Muscular Fiber

NCT02900300 | Completed

• 1 other identifier: RECHMPL15_0389
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This non-interventional study focuses on mechanical ventilation used in intensive care unit to supplement ventilatory function in patients. Mechanical ventilation can "paradoxically" be at the origin of complications that can be life-threatening in patients. This muscular pathology is called ventilation-induced diaphragmatic dysfunction (DDIV). Diaphragmatic muscle collected during a digestive surgery for a benign or malignant tumor of the liver requiring surgical excision in contact with the diaphragm from the care will be conserved. The diaphragm biopsy from the care will be retained for biobanking to obtain myoblast in culture which will differentiate in Diaphragm fiber. Then these fibers will be submitted under mechanical stress condition similar to those imposed in vivo by mechanical ventilation to validate in human a model in vitro of diaphragm dysfunction induced by mechanical ventilation. Then the second part of the study will be to evaluate with this model, the efficiency of an antioxidant therapy.

Conditions

Diaphragm Dysfunction; Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• Myoblast differentiation capacity

  Description: evaluation of ROS (reactive oxygen species) production by confocal microscopie of diaphragm fiber submitted in vitro by mechanical stress.

  24 month

Secondary Outcomes (1)

• Myoblast proliferation capacity

  24 month

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient undergoing a surgery for a benign or malignant tumor of the liver requiring surgical excision in contact with the diaphragm

You may qualify if:

• age between 30 and 65 years old
• patient treated by the digestive surgery department of Montpellier University Hospital for a benign or malignant tumor of the liver requiring surgical excision in contact with the diaphragm
• Non-smoker patient for more than 6 months
• patient clinically stable at the time of the study, ie not requiring any treatment

You may not qualify if:

• Patients undergoing treatment with antibiotics or corticosteroids, or recently within the last 4 months
• Patients with a body mass index \> 30
• Patients with any criteria that may in themselves impair respiratory muscle function such as chronic obstructive pulmonary disease, heart failure, systemic infection, neuromuscular pathology, psychiatric pathology or metabolic disorder.
• Patients with coagulopathy or thrombocytopenia.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital

Montpellier, 34295, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Diaphragmatic muscle collected during a digestive surgery for a benign or malignant tumor of the liver requiring surgical excision in contact with the diaphragm from the care will be conserved.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: September 14, 2016
• Study Start: February 18, 2022
• Primary Completion: May 23, 2024
• Study Completion: May 23, 2024
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

FR (1)