HepaRAS Trial: Changes in Hepatectomy Risk Assessment When Using Mebrofenin HIDA

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.

Conditions

• Liver Failure as A Complication of Care
• 30-day Mortality

Interventions

DIAGNOSTIC_TEST

mHBS

Preoperative FLRF assessment using 99mTc-mebrofenin hepatobiliary scintigraphy (mHBS).

DIAGNOSTIC_TEST

CT/MRI volumetry

Preoperative FLRF assessment using CT/MRI volumetry

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre

  collaborator OTHER

• Boris Gala Lopez

  lead OTHER

Principal Investigators

• Boris Gala-Lopez, MD, MSC, PhD · Queen Elizabeth II Health Sciences Centre. Dalhousie University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-15

Primary Completion

2025-02-28

Completion

2025-07-30