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

Liver Failure as A Complication of Care Clinical Trial

— HepaRAS  

Official title:

HepaRAS Trial: Changes in Hepatectomy Risk Assessment When Incorporating Mebrofenin HIDA for Functional Evaluation of the Liver Remnant: A Pilot Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05280990
• Other study ID #: 45465
• Status: Withdrawn
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: July 30, 2025

Study information

• Verified date: February 2024
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 30, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Liver Failure
• Liver Failure as A Complication of Care

Intervention

Diagnostic Test:
• mHBS
Preoperative FLRF assessment using 99mTc-mebrofenin hepatobiliary scintigraphy (mHBS).
• CT/MRI volumetry
Preoperative FLRF assessment using CT/MRI volumetry

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Boris Gala Lopez	McGill University Health Centre/Research Institute of the McGill University Health Centre

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with post-hepatectomy liver failure (PHLF)	Incidence of post-hepatectomy liver failure (PHLF)	30 days
Secondary	Number of participants with the 50-50 criteria	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.	5 days
Secondary	Number of participants with major postoperative complications as per Clavien-Dindo classification	Occurrence of major postoperative complications as per Clavien-Dindo classification	30 days
Secondary	Hospital length of stay	Hospital length of stay	30 days
Secondary	30-day mortality	30-day mortality	30 days