Liver Failure as A Complication of CareHepaRASNCT05280990
HepaRAS Trial: Changes in Hepatectomy Risk Assessment When Using Mebrofenin HIDA
A study testing mHBS and CT/MRI volumetry in people with Liver Failure as A Complication of Care and 30-day Mortality, run by Boris Gala Lopez.
Trial summary
Surgical procedures to remove a significant portion of the liver are used to treat various diseases including cancer. They have demonstrated to be the most effective treatment for selected patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Failure as A Complication of Care, 30-day Mortality
- What is being tested?
- mHBS and CT/MRI volumetry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2023to 30 Jul 2025
- Phase
- Interventional
- 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
Who may be able to join
- All adult patients who are being considered for major hepatectomy at the QEII and McGill for malignant or benign disease.
- Both open and laparoscopic approaches will be accepted in the study.
- Patients with underlying liver cirrhosis or receiving additional ablation therapies will not be excluded.
Who cannot join
- Patients younger than 18 years-old.
- Pregnant patients.
- Hepatectomy is associated with another major non-liver procedure.
- Patients not qualifying for a major hepatectomy following preoperative assessment.
About this study
Official title: HepaRAS Trial: Changes in Hepatectomy Risk Assessment When Incorporating Mebrofenin HIDA for Functional Evaluation of the Liver Remnant: A Pilot Study
Surgical procedures to remove a significant portion of the liver are used to treat various diseases including cancer. They have demonstrated to be the most effective treatment for selected patients. These procedures rely on the fascinating ability of the liver to grow back, allowing surgeons to remove of up to 70% of the organ in a safe manner. However, there are instances where severe complications and death occur due to the inability of the residual liver to perform all functions. It is estimated that up to 32% of patients undergoing this type of surgery will experience such complications. To prevent this, physicians calculate the total liver volume before surgery using radiology and estimate how much liver will remain after surgery. Only when the liver remnant is 30% or higher, the procedure is deemed safe.
One of the main limitations of this strategy is that the estimated percentage of the liver remnant does not entirely reflect a proportional function. To overcome this limitation and avoid serious complications, a more precise assessment is required. Recently, a new scan was introduced using mebrofenin, which is metabolized in the liver and can be traced in a particular region of the organ using computer software. As a result, clinicians can know with certainty, the percentual function of a portion of the liver, and if that portion will be sufficient to avoid complications and death after a major liver operation.
Read more
This project proposes incorporating this technology for preoperative evaluation against our traditional assessment using just volume calculations. Participants will be randomly assigned to the traditional volume calculation or the new scan with mebrofenin, and investigators will compare how well both methods are able to predict complications and death after surgery. Researchers are particularly interested in demonstrating if major complications and death after surgery are less using the new mebrofenin scan.
Our study evaluating the introduction of a new and relatively harmful technique will help to better identify those patients with high risk for complications and death after a major surgical procedure on the liver. This will help in better selecting future patients and will allow for a more precise discussion during initial evaluation.
Read the detailed description
Surgical procedures to remove a significant portion of the liver are used to treat various diseases, including cancer. They have been demonstrated to be the most effective treatment for selected patients. These procedures rely on the fascinating ability of the liver to grow back, allowing surgeons to remove up to 70% of the organ in a safe manner. However, there are instances where severe complications and death occur due to the inability of the residual liver to perform all functions. It is estimated that up to 32% of patients undergoing this type of surgery will experience such complications. To prevent this, physicians use radiology to calculate the total liver volume before surgery and estimate how much liver will remain after surgery. The procedure is deemed safe only when the liver remnant is 30% or higher.
One of the main limitations of this strategy is that the estimated percentage of the liver remnant does not entirely reflect a proportional function. A more precise assessment is required to overcome this limitation and avoid serious complications. Recently, a new scan was introduced using computer software using mebrofenin, which is metabolized in the liver and can be traced in a particular organ region. As a result, clinicians can know with certainty the percentual function of a portion of the liver and if that portion will be sufficient to avoid complications and death after a major liver operation.
This project proposes incorporating this technology for preoperative evaluation against our traditional assessment using just volume calculations. Participants will be randomly assigned to the traditional volume calculation or the new scan with mebrofenin, and investigators will compare how well both methods are able to predict complications and death after surgery. Researchers are particularly interested in demonstrating if major complications and death after surgery are less common using the new mebrofenin scan.
Our study evaluating the introduction of a new and relatively harmful technique will help to better identify those patients with a high risk for complications and death after a major surgical procedure on the liver. This will help better select future patients and allow for a more precise discussion during the initial evaluation.
- Being tested
- mHBS, CT/MRI volumetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHBSDiagnostic test
Preoperative FLRF assessment using 99mTc-mebrofenin hepatobiliary scintigraphy (mHBS).
CT/MRI volumetryDiagnostic test
Preoperative FLRF assessment using CT/MRI volumetry
| Study group | Role | What they receive |
|---|---|---|
| Future Liver Remnant Function (FLRF) | Experimental | Preoperative FLRF risk assessment via 99mTc-mebrofenin hepatobiliary scintigraphy (mHBS) Receives: Diagnostic Test: mHBS |
| Future Liver Remnant Volume (FLRV) | Active comparator | Preoperative FLRV assessment by CT/MRI volumetry Receives: Diagnostic Test: CT/MRI volumetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with post-hepatectomy liver failure (PHLF)
Incidence of post-hepatectomy liver failure (PHLF)
Measured: 30 days
Secondary outcomes (4)
Number of participants with the 50-50 criteria
Prothrombin time <50% of normal and serum bilirubin >50 µmol/L on POD 5, which is an early predictor of more than 50% mortality rate after hepatectomy.
Measured: 5 days
Number of participants with major postoperative complications as per Clavien-Dindo classification
Occurrence of major postoperative complications as per Clavien-Dindo classification
Measured: 30 days
Hospital length of stay
Hospital length of stay
Measured: 30 days
30-day mortality
30-day mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start15 Jan 2023 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Why it stopped: Technical requirements not met.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Liver Failure as A Complication of CareStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Hypothesis: Using Future Liver Remnant Function (FLRF) through 99mTc-mebrofenin hepatobiliary scintigraphy (mHBS) to select patients for major hepatectomy will reduce the rate of Post-hepatectomy liver failure (PHLF), compared to our standard-of-care Future Liver Remnant Volume (FLRV) calculations for patient selection. Methods: This is a prospective pilot study designed to evaluate feasibility and safety in the Canadian settings and will include patients undergoing major liver resection at the Queen Elizabeth II Health Sciences Centre (QEII) in Halifax, Canada, and at McGill University Health Centre in Montreal, Canada (McGill). Recruited patients, irrespective of their underlying liver quality will be randomly assigned via block randomization to have either preoperative FLRV assessment by CT/MRI volumetry or preoperative FLRF risk assessment via mHBS.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boris Gala Lopez
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Responsible party
- Sponsor-investigator, Boris Gala Lopez, Nova Scotia Health Authority
- Investigators
- Boris Gala-Lopez, MD, MSC, PhD, Principal investigator, Queen Elizabeth II Health Sciences Centre. Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280990
- Sponsor's protocol ID
- 45465
- Acronym
- HepaRAS
- Status last verified
- Feb 2024
- First submitted
- 6 Mar 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guglielmi A, Ruzzenente A, Conci S, Valdegamberi A, Iacono C. How much remnant is enough in liver resection? Dig Surg. 2012;29(1):6-17. doi: 10.1159/000335713. Epub 2012 Mar 15.
PubMed 22441614Gupta M, Choudhury PS, Singh S, Hazarika D. Liver Functional Volumetry by Tc-99m Mebrofenin Hepatobiliary Scintigraphy before Major Liver Resection: A Game Changer. Indian J Nucl Med. 2018 Oct-Dec;33(4):277-283. doi: 10.4103/ijnm.IJNM_72_18.
PubMed 30386047de Graaf W, van Lienden KP, Dinant S, Roelofs JJ, Busch OR, Gouma DJ, Bennink RJ, van Gulik TM. Assessment of future remnant liver function using hepatobiliary scintigraphy in patients undergoing major liver resection. J Gastrointest Surg. 2010 Feb;14(2):369-78. doi: 10.1007/s11605-009-1085-2.
PubMed 19937195Bennink RJ, Dinant S, Erdogan D, Heijnen BH, Straatsburg IH, van Vliet AK, van Gulik TM. Preoperative assessment of postoperative remnant liver function using hepatobiliary scintigraphy. J Nucl Med. 2004 Jun;45(6):965-71.
PubMed 15181131
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HepaRAS Trial: Changes in Hepatectomy Risk Assessment When Incorporating Mebrofenin HIDA for Functional Evaluation of the Liver Remnant: A Pilot Study
- ClinicalTrials.gov ID
- NCT05280990
- Acronym / sponsor ID
- HepaRAS / 45465
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Technical requirements not met.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boris Gala LopezUniversity, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Study start
- 15 Jan 2023 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 15 Mar 2022 (actual)
- 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.
Surgical procedures to remove a significant portion of the liver are used to treat various diseases including cancer. They have demonstrated to be the most effective treatment for selected patients. These procedures rely on the fascinating ability of the liver to grow back, allowing surgeons to remove of up to 70% of the organ in a safe manner. However, there are instances where severe complications and death occur due to the inability of the residual liver to perform all functions. It is estimated that up to 32% of patients undergoing this type of surgery will experience such complications. To prevent this, physicians calculate the total liver volume before surgery using radiology and estimate how much liver will remain after surgery. Only when the liver remnant is 30% or higher, the procedure is deemed safe.
One of the main limitations of this strategy is that the estimated percentage of the liver remnant does not entirely reflect a proportional function. To overcome this limitation and avoid serious complications, a more precise assessment is required. Recently, a new scan was introduced using mebrofenin, which is metabolized in the liver and can be traced in a particular region of the organ using computer software. As a result, clinicians can know with certainty, the percentual function of a portion of the liver, and if that portion will be sufficient to avoid complications and death after a major liver operation.
This project proposes incorporating this technology for preoperative evaluation against our traditional assessment using just volume calculations. Participants will be randomly assigned to the traditional volume calculation or the new scan with mebrofenin, and investigators will compare how well both methods are able to predict complications and death after surgery. Researchers are particularly interested in demonstrating if major complications and death after surgery are less using the new mebrofenin scan.
Our study evaluating the introduction of a new and relatively harmful technique will help to better identify those patients with high risk for complications and death after a major surgical procedure on the liver. This will help in better selecting future patients and will allow for a more precise discussion during initial evaluation.
Detailed description
Surgical procedures to remove a significant portion of the liver are used to treat various diseases, including cancer. They have been demonstrated to be the most effective treatment for selected patients. These procedures rely on the fascinating ability of the liver to grow back, allowing surgeons to remove up to 70% of the organ in a safe manner. However, there are instances where severe complications and death occur due to the inability of the residual liver to perform all functions. It is estimated that up to 32% of patients undergoing this type of surgery will experience such complications. To prevent this, physicians use radiology to calculate the total liver volume before surgery and estimate how much liver will remain after surgery. The procedure is deemed safe only when the liver remnant is 30% or higher.
One of the main limitations of this strategy is that the estimated percentage of the liver remnant does not entirely reflect a proportional function. A more precise assessment is required to overcome this limitation and avoid serious complications. Recently, a new scan was introduced using computer software using mebrofenin, which is metabolized in the liver and can be traced in a particular organ region. As a result, clinicians can know with certainty the percentual function of a portion of the liver and if that portion will be sufficient to avoid complications and death after a major liver operation.
This project proposes incorporating this technology for preoperative evaluation against our traditional assessment using just volume calculations. Participants will be randomly assigned to the traditional volume calculation or the new scan with mebrofenin, and investigators will compare how well both methods are able to predict complications and death after surgery. Researchers are particularly interested in demonstrating if major complications and death after surgery are less common using the new mebrofenin scan.
Our study evaluating the introduction of a new and relatively harmful technique will help to better identify those patients with a high risk for complications and death after a major surgical procedure on the liver. This will help better select future patients and allow for a more precise discussion during the initial evaluation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Hypothesis: Using Future Liver Remnant Function (FLRF) through 99mTc-mebrofenin hepatobiliary scintigraphy (mHBS) to select patients for major hepatectomy will reduce the rate of Post-hepatectomy liver failure (PHLF), compared to our standard-of-care Future Liver Remnant Volume (FLRV) calculations for patient selection. Methods: This is a prospective pilot study designed to evaluate feasibility and safety in the Canadian settings and will include patients undergoing major liver resection at the Queen Elizabeth II Health Sciences Centre (QEII) in Halifax, Canada, and at McGill University Health Centre in Montreal, Canada (McGill). Recruited patients, irrespective of their underlying liver quality will be randomly assigned via block randomization to have either preoperative FLRV assessment by CT/MRI volumetry or preoperative FLRF risk assessment via mHBS.
| Arm | Type | Receives |
|---|---|---|
| Future Liver Remnant Function (FLRF) | Experimental | Diagnostic Test: mHBSPreoperative FLRF risk assessment via 99mTc-mebrofenin hepatobiliary scintigraphy (mHBS) |
| Future Liver Remnant Volume (FLRV) | Active comparator | Diagnostic Test: CT/MRI volumetryPreoperative FLRV assessment by CT/MRI volumetry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All adult patients who are being considered for major hepatectomy at the QEII and McGill for malignant or benign disease.
- Both open and laparoscopic approaches will be accepted in the study.
- Patients with underlying liver cirrhosis or receiving additional ablation therapies will not be excluded.
Key exclusion criteria (4 listed)
- Patients younger than 18 years-old.
- Pregnant patients.
- Hepatectomy is associated with another major non-liver procedure.
- Patients not qualifying for a major hepatectomy following preoperative assessment.
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 |
|---|---|---|
| mHBSPreoperative FLRF assessment using 99mTc-mebrofenin hepatobiliary scintigraphy (mHBS). | Diagnostic test | Future Liver Remnant Function (FLRF) |
| CT/MRI volumetryPreoperative FLRF assessment using CT/MRI volumetry | Diagnostic test | Future Liver Remnant Volume (FLRV) |
Primary outcome
Number of participants with post-hepatectomy liver failure (PHLF)
Time frame: 30 days
Incidence of post-hepatectomy liver failure (PHLF)
4 secondary outcomes
Number of participants with the 50-50 criteria
Time frame: 5 days
Number of participants with major postoperative complications as per Clavien-Dindo classification
Time frame: 30 days
Hospital length of stay
Time frame: 30 days
30-day mortality
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Background: PubMed 22441614Guglielmi A, Ruzzenente A, Conci S, Valdegamberi A, Iacono C. How much remnant is enough in liver resection? Dig Surg. 2012;29(1):6-17. doi: 10.1159/000335713. Epub 2012 Mar 15.
- Background: PubMed 30386047Gupta M, Choudhury PS, Singh S, Hazarika D. Liver Functional Volumetry by Tc-99m Mebrofenin Hepatobiliary Scintigraphy before Major Liver Resection: A Game Changer. Indian J Nucl Med. 2018 Oct-Dec;33(4):277-283. doi: 10.4103/ijnm.IJNM_72_18.
- Background: PubMed 19937195de Graaf W, van Lienden KP, Dinant S, Roelofs JJ, Busch OR, Gouma DJ, Bennink RJ, van Gulik TM. Assessment of future remnant liver function using hepatobiliary scintigraphy in patients undergoing major liver resection. J Gastrointest Surg. 2010 Feb;14(2):369-78. doi: 10.1007/s11605-009-1085-2.
- Background: PubMed 15181131Bennink RJ, Dinant S, Erdogan D, Heijnen BH, Straatsburg IH, van Vliet AK, van Gulik TM. Preoperative assessment of postoperative remnant liver function using hepatobiliary scintigraphy. J Nucl Med. 2004 Jun;45(6):965-71.
- Individual participant dataSharing planned: No
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.
Boris Gala-Lopez, MD, MSC, PhD principal investigator
Queen Elizabeth II Health Sciences Centre. Dalhousie University
Questions about this trial
What is this clinical trial studying?
A study testing mHBS and CT/MRI volumetry in people with Liver Failure as A Complication of Care and 30-day Mortality, run by Boris Gala Lopez.
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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Number of participants with post-hepatectomy liver failure (PHLF) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05280990, which also lists 4 linked publications.
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 7 Feb 2024.