HepaRAS Trial: Changes in Hepatectomy Risk Assessment When Using Mebrofenin HIDA
- Conditions
- 30-day MortalityLiver Failure as A Complication of Care
- Interventions
- Diagnostic Test: CT/MRI volumetryDiagnostic Test: mHBS
- Registration Number
- NCT05280990
- Lead Sponsor
- Boris Gala Lopez
- Brief 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. 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Future Liver Remnant Volume (FLRV) CT/MRI volumetry Preoperative FLRV assessment by CT/MRI volumetry Future Liver Remnant Function (FLRF) mHBS Preoperative FLRF risk assessment via 99mTc-mebrofenin hepatobiliary scintigraphy (mHBS)
- Primary Outcome Measures
Name Time Method Number of participants with post-hepatectomy liver failure (PHLF) 30 days Incidence of post-hepatectomy liver failure (PHLF)
- Secondary Outcome Measures
Name Time Method Number of participants with major postoperative complications as per Clavien-Dindo classification 30 days Occurrence of major postoperative complications as per Clavien-Dindo classification
Number of participants with the 50-50 criteria 5 days 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.
Hospital length of stay 30 days Hospital length of stay
30-day mortality 30 days 30-day mortality