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

NCT ID: NCT05280990

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-15
• Study Completion Date: 2025-07-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Future Liver Remnant Function (FLRF)

Preoperative FLRF risk assessment via 99mTc-mebrofenin hepatobiliary scintigraphy (mHBS)

Group Type: EXPERIMENTAL

mHBS

Intervention Type: DIAGNOSTIC_TEST

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

Future Liver Remnant Volume (FLRV)

Preoperative FLRV assessment by CT/MRI volumetry

Group Type: ACTIVE_COMPARATOR

CT/MRI volumetry

Intervention Type: DIAGNOSTIC_TEST

Preoperative FLRF assessment using CT/MRI volumetry

Interventions

mHBS

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

Intervention Type: DIAGNOSTIC_TEST

CT/MRI volumetry

Preoperative FLRF assessment using CT/MRI volumetry

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: collaborator

Boris Gala Lopez

OTHER

Sponsor Role: lead

Responsible Party

Boris Gala Lopez

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Boris Gala-Lopez, MD, MSC, PhD

Role: PRINCIPAL_INVESTIGATOR

Queen Elizabeth II Health Sciences Centre. Dalhousie University

References

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.

Reference Type: BACKGROUND

PMID: 22441614 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30386047 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19937195 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15181131 (View on PubMed)

Other Identifiers

45465

Identifier Type: -

Identifier Source: org_study_id