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

NCT05280990 | Withdrawn

• 1 other identifier: 45465
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Number of participants with post-hepatectomy liver failure (PHLF)

  Incidence of post-hepatectomy liver failure (PHLF)

  30 days

Secondary Outcomes (4)

• Number of participants with the 50-50 criteria

  5 days

• Number of participants with major postoperative complications as per Clavien-Dindo classification

  30 days

• Hospital length of stay

  30 days

• 30-day mortality

  30 days

Study Arms (2)

Future Liver Remnant Function (FLRF)

EXPERIMENTAL

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

Diagnostic Test: mHBS

Future Liver Remnant Volume (FLRV)

ACTIVE COMPARATOR

Preoperative FLRV assessment by CT/MRI volumetry

Diagnostic Test: CT/MRI volumetry

Interventions

mHBS DIAGNOSTIC_TEST

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

Future Liver Remnant Function (FLRF)

CT/MRI volumetry DIAGNOSTIC_TEST

Preoperative FLRF assessment using CT/MRI volumetry

Future Liver Remnant Volume (FLRV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boris Gala Lopez: lead
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator

Related Publications (4)

• 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.

  PMID: 22441614 BACKGROUND

• 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.

  PMID: 30386047 BACKGROUND

• 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.

  PMID: 19937195 BACKGROUND

• 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.

  PMID: 15181131 BACKGROUND

Study Officials

• Boris Gala-Lopez, MD, MSC, PhD

  Queen Elizabeth II Health Sciences Centre. Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 6, 2022
• First Posted: March 15, 2022
• Study Start: January 15, 2023
• Primary Completion: February 28, 2025
• Study Completion: July 30, 2025
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share