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Completed

NCT Number: NCT02031094

Energy Expenditure and Regeneration Following Liver Resection Resection

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Infirmary of Edinburgh

Edinburgh, Lothian, EH16 4SA, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

Observational methods of measuring resting energy expenditure

Primary outcomes

  1. Change in Resting Energy Expenditure (Kcal) following liver resection

    Time frame: 2 weeks pre-operatively and post-operative days 3,5 and 7

Secondary outcomes

  1. Change in total energy expenditure (Kcal) following liver resection

    Time frame: 2 weeks pre-operatively and post-operative days 3,5 and 7

Other outcomes

  1. Volume of liver resected (g)

    Time frame: Post operative day 1

  2. Resting energy expenditure (REE) (Kcal)

    Time frame: 4 weeks post-operative

  3. Post-operative blood tests (FBC, U&E, LFT, Coag)

    Time frame: Post-operative days 1-7

  4. Complications

    Time frame: Day of surgery and post-operative days 1-30

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • Royal College of Surgeons of Edinburgh

Registry information

Official study title

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

Acronym: EAGLE

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 9, 2014
Registry last updated
Oct 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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