Liver ResectionEAGLENCT02031094
Energy Expenditure and Regeneration Following Liver Resection Resection
An observational study of Liver Resection, run by University of Edinburgh at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Resection
- What is being tested?
- Observational study: Sense Wear armband and indirect calorimetry used to measure resting energy expenditure
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2014to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing hepatic resection for benign or malignant neoplasms.
Who may be able to join
- Patients undergoing liver resection for benign or malignant hepatic neoplasm
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Infirmary of Edinburgh
Edinburgh, Lothian, EH16 4SA
About this study
Official title: 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.
Read the 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
- Being tested
- Observational study: Sense Wear armband and indirect calorimetry used to measure resting energy expenditure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study: Sense Wear armband and indirect calorimetry used to measure resting energy expenditureOther
Observational methods of measuring resting energy expenditure
| Study group | Role | What they receive |
|---|---|---|
| Major resection | Patients undergoing resection of >3 segments (resting energy expenditure measured by Sense Wear Armband and indirect calorimetry) Receives: Other: Observational study: Sense Wear armband and indirect calorimetry used to measure resting energy expenditure | |
| Minor resection | Patients undergoing resection of </= 3 segments (resting energy expenditure measured by Sense Wear Armband and indirect calorimetry) Receives: Other: Observational study: Sense Wear armband and indirect calorimetry used to measure resting energy expenditure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Resting Energy Expenditure (Kcal) following liver resection
Measured: 2 weeks pre-operatively and post-operative days 3,5 and 7
Secondary outcomes (1)
Change in total energy expenditure (Kcal) following liver resection
Measured: 2 weeks pre-operatively and post-operative days 3,5 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver ResectionStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Royal College of Surgeons of Edinburgh
- Responsible party
- Sponsor
- Investigators
- Michael j Hughes, Principal investigator, University of EdinburghStephen J Wigmore, Study director, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031094
- Sponsor's protocol ID
- 13/SS/0019
- Other IDs
- 2013/R/END/01
- Acronym
- EAGLE
- Status last verified
- Oct 2014
- First submitted
- 21 Nov 2013
- Last updated
- 16 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Liver Regeneration on Resting Energy Expenditure After Liver Resectional Surgery
- ClinicalTrials.gov ID
- NCT02031094
- Acronym / sponsor ID
- EAGLE / 13/SS/0019
- Conditions
- Liver Resection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- Royal College of Surgeons of Edinburgh
- Study start
- Jan 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 9 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Major resection | – | Other: Observational study: Sense Wear armband and indirect calorimetry used to measure resting energy expenditurePatients undergoing resection of >3 segments (resting energy expenditure measured by Sense Wear Armband and indirect calorimetry) |
| Minor resection | – | Other: Observational study: Sense Wear armband and indirect calorimetry used to measure resting energy expenditurePatients undergoing resection of </= 3 segments (resting energy expenditure measured by Sense Wear Armband and indirect calorimetry) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing hepatic resection for benign or malignant neoplasms.
Key inclusion criteria (1 listed)
- Patients undergoing liver resection for benign or malignant hepatic neoplasm
Key exclusion criteria (6 listed)
- Inability to give written, informed consent.
- Jaundice (Bilirubin > 100 μmol/L)
- Liver resection combined with secondary surgical procedure.
- Age < 18 years
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study: Sense Wear armband and indirect calorimetry used to measure resting energy expenditureObservational methods of measuring resting energy expenditure | Other | Major resection, Minor resection |
Primary outcome
Change in Resting Energy Expenditure (Kcal) following liver resection
Time frame: 2 weeks pre-operatively and post-operative days 3,5 and 7
1 secondary outcome
Change in total energy expenditure (Kcal) following liver resection
Time frame: 2 weeks pre-operatively and post-operative days 3,5 and 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael j Hughes principal investigator
University of Edinburgh
Stephen J Wigmore study director
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Resection, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Resting Energy Expenditure (Kcal) following liver resection (time frame: 2 weeks pre-operatively and post-operative days 3,5 and 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2014.