Energy Expenditure and Regeneration Following Liver Resection Resection

NCT ID: NCT02031094

Last Updated: 2014-10-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 28 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-09-30

Brief Summary

This observational study will measure resting energy expenditure in patients who have undergone liver resection and compare methods of measuring resting energy expenditure.

Detailed Description

Penetrating liver injury occurs commonly in victims of battlefield trauma. It is associated with a high mortality and morbidity rate. Management of liver injury is complex and challenging and can often involve debridement or anatomical resection of liver tissue.

Following liver resection, the liver regenerates to its original volume. Liver regeneration involves complex metabolic processes and maximal regeneration occurs over the first post operative week. This process is highly energy dependent and adds a further burden on post operative energy and therefore nutritional requirements.

Inadequate post-operative nutrition is associated with poorer outcomes and complication rates. Additionally, over feeding is also associated with adverse outcome. The actual additional energy expenditure involved in liver regeneration is not currently known and therefore accurate calorific balance remains a challenge.

The measurement of energy expenditure in these patients is therefore important. Traditionally energy expenditure has been measured by indirect calorimetry and doubly labelled water. These techniques require skilled operators and are often impractical for everyday clinical usage and impossible in the deployed setting.

A recent development is a lightweight armband that measures total and resting energy expenditure. It has been validated against the gold standard techniques in various settings including cancer cachexia, obesity and healthy volunteers and is deemed highly acceptable also. It has not been validated in the unique setting of liver regeneration.

Therefore this study will assess the energy expenditure in patients undergoing liver regeneration and attempt to validate a new minimally invasive device against the traditional measurements of energy expenditure.

Conditions

Liver Resection

Study Design

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

Study Groups

Major resection

Patients undergoing resection of \>3 segments (resting energy expenditure measured by Sense Wear Armband and indirect calorimetry)

Observational study: Sense Wear armband and indirect calorimetry used to measure resting energy expenditure

Intervention Type: OTHER

Observational methods of measuring resting energy expenditure

Minor resection

Patients undergoing resection of \</= 3 segments (resting energy expenditure measured by Sense Wear Armband and indirect calorimetry)

Observational study: Sense Wear armband and indirect calorimetry used to measure resting energy expenditure

Intervention Type: OTHER

Observational methods of measuring resting energy expenditure

Interventions

Observational study: Sense Wear armband and indirect calorimetry used to measure resting energy expenditure

Observational methods of measuring resting energy expenditure

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients undergoing liver resection for benign or malignant hepatic neoplasm

Exclusion Criteria

• Inability to give written, informed consent.
• Jaundice (Bilirubin > 100 μmol/L)
• Liver resection combined with secondary surgical procedure.
• Age < 18 years
• Pregnant women
• Unable to tolerate either measuring device

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

Sponsors

Royal College of Surgeons of Edinburgh

OTHER

Sponsor Role: collaborator

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael j Hughes

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Stephen J Wigmore

Role: STUDY_DIRECTOR

University of Edinburgh

Locations

Royal Infirmary of Edinburgh

Edinburgh, Lothian, United Kingdom

Countries

United Kingdom

Other Identifiers

2013/R/END/01

Identifier Type: OTHER

Identifier Source: secondary_id

13/SS/0019

Identifier Type: -

Identifier Source: org_study_id