Energy Expenditure and Regeneration Following Liver Resection Resection (EAGLE)

The Effect of Liver Regeneration on Resting Energy Expenditure After Liver Resectional Surgery

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

Study Overview

• Status: Completed
• Conditions: Liver Resection
• Intervention / Treatment: Other: Observational study: Sense Wear armband and indirect calorimetry used to measure 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.

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• United Kingdom
  • Lothian
    • Edinburgh, Lothian, United Kingdom, EH16 4SA
      • Royal Infirmary of Edinburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients undergoing hepatic resection for benign or malignant neoplasms.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Major resection; Patients undergoing resection of >3 segments (resting energy expenditure measured by Sense Wear Armband and indirect calorimetry)	Other: Observational study: Sense Wear armband and indirect calorimetry used to measure resting energy expenditure; 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)	Other: Observational study: Sense Wear armband and indirect calorimetry used to measure resting energy expenditure; Observational methods of measuring resting energy expenditure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Resting Energy Expenditure (Kcal) following liver resection	2 weeks pre-operatively and post-operative days 3,5 and 7

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in total energy expenditure (Kcal) following liver resection	2 weeks pre-operatively and post-operative days 3,5 and 7

Other Outcome Measures

Outcome Measure	Time Frame
Complications	Day of surgery and post-operative days 1-30
Volume of liver resected (g)	Post operative day 1
Resting energy expenditure (REE) (Kcal)	4 weeks post-operative
Post-operative blood tests (FBC, U&E, LFT, Coag)	Post-operative days 1-7

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Collaborators: Royal College of Surgeons of Edinburgh
• Investigators: Principal Investigator: Michael j Hughes, University of Edinburgh; Study Director: Stephen J Wigmore, University of Edinburgh

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: November 21, 2013
• First Submitted That Met QC Criteria: January 7, 2014
• First Posted (Estimate): January 9, 2014

Study Record Updates

• Last Update Posted (Estimate): October 16, 2014
• Last Update Submitted That Met QC Criteria: October 15, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 13/SS/0019; 2013/R/END/01 (Other Identifier: NHS Lothian)