HepaRAS TRIAL: CHANGES IN HEPATECTOMY RISK ASSESSMENT WHEN INCORPORATING MEBROFENIN HIDA
Study Details
Study Description
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, we 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 we will compare how well both methods are able to predict complications and death after surgery. We 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Future Liver Remnant Function (FLRF) Preoperative FLRF risk assessment via 99mTc-mebrofenin hepatobiliary scintigraphy (mHBS) |
Diagnostic Test: mHBS
Preoperative FLRF assessment using 99mTc-mebrofenin hepatobiliary scintigraphy (mHBS).
|
| Active Comparator: Future Liver Remnant Volume (FLRV) Preoperative FLRV assessment by CT/MRI volumetry |
Diagnostic Test: CT/MRI volumetry
Preoperative FLRF assessment using CT/MRI volumetry
|
Outcome Measures
Primary Outcome Measures
- Post-hepatectomy liver failure (PHLF) [30 days]
Post-hepatectomy liver failure (PHLF)
Secondary Outcome Measures
- 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.
- Postoperative complications as per Clavien-Dindo classification [30 days]
Postoperative complications as per Clavien-Dindo classification
- Hospital length of stay [30 days]
Hospital length of stay
- 30-day mortality [30 days]
30-day mortality
Eligibility Criteria
Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Patients will be excluded if younger than 18 years-old, pregnant, or if the hepatectomy is associated with another major non-liver procedure. Patients will also be excluded if they do not qualify for major hepatectomy following FLRF or FLRV assessment.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Nova Scotia Health Authority
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Investigators
- Principal Investigator: Boris Gala-Lopez, MD, MSC, PhD, Queen Elizabeth II Health Sciences Centre. Dalhousie University
Study Documents (Full-Text)
None provided.More Information
Publications
- Bennink 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.
- de 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.
- 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. Review.
- Gupta 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. Review.
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