Energy Expenditure and Regeneration Following Liver Resection Resection

Liver Resection Clinical Trial

— EAGLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02031094
• Other study ID #: 13/SS/0019
• Secondary ID: 2013/R/END/01
• Status: Completed
• Phase: N/A
• First received: November 21, 2013
• Last updated: October 15, 2014
• Start date: January 2014
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: NHS Lothian/University of Edinburgh
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Liver Resection

Intervention

Other:
• Observational study: Sense Wear armband and indirect calorimetry used to measure resting energy expenditure
Observational methods of measuring resting energy expenditure

Locations

Country	Name	City	State
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh	Lothian

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	Royal College of Surgeons of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Volume of liver resected (g)		Post operative day 1	No
Other	Resting energy expenditure (REE) (Kcal)		4 weeks post-operative	No
Other	Post-operative blood tests (FBC, U&E, LFT, Coag)		Post-operative days 1-7	No
Other	Complications		Day of surgery and post-operative days 1-30	No
Primary	Change in Resting Energy Expenditure (Kcal) following liver resection		2 weeks pre-operatively and post-operative days 3,5 and 7	No
Secondary	Change in total energy expenditure (Kcal) following liver resection		2 weeks pre-operatively and post-operative days 3,5 and 7	No