Hepato Biliary Scintigraphy to Assess the Risk of Postoperative Liver Failure Hepatectomies

NCT ID: NCT02753517

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 326 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-08
• Study Completion Date: 2021-12-10

Brief Summary

Extended hepatectomies of 4 or more segments are complicated by high rates of morbidity and mortality, mainly related to hepatic liver failure. Nowadays, preoperative assessment of the future remnant liver is just performed through its volumetric measurement by computed tomography. Nevertheless, this volumetric assessment does not reflect the hepatocellular function of the future remnant liver that can be disturbed in case of vascular and/or biliary obstruction, chemotherapy-induced liver injuries or steatosis in overweight patients. Literature data (albeit originating from a single centre in Europe) have suggested that (99m)Tc-mebrofenin hepatobiliary scintigraphy could be useful in evaluating the function of the future remnant liver. The aim of this prospective multicentric study is to determine the predictive value of hepatobiliary scintigraphy in assessing the risk of postoperative liver failure of extended hepatectomies of 4 or more segments in noncirrhotic liver.

Detailed Description

The main aim of the study is to determine the predictive value of (99m)Tc-mebrofenin hepatobiliary scintigraphy in assessing the postoperative risk of liver failure within 3 months of extended hepatectomy of 4 or more segments in noncirrhotic liver. The main endpoint is the three-months postoperative liver failure, defined as an increased International Normalized Ratio (INR) and concomitant hyperbilirubinemia (according to the normal limits of the local laboratory) on or after postoperative day 5 according to the international classification of the ISGLS (International Study Group of Liver Surgery) and classified according to its severity in grade A (no change of the patient's clinical management), grade B (deviation from the regular course but without invasive therapy) and grade C (invasive treatment)

Secondary objectives are:

To determine the predictive value of (99m)Tc-mebrofenin hepatobiliary scintigraphy in assessing the risk of postoperative morbi-mortality (according to Clavien-Dindo classification) within 3 months of extended hepatectomy of 4 or more segments in noncirrhotic liver, and the duration of intensive care unit stay and of hospitalization.

• To assess the correlation between the results of the hepatobiliary scintigraphy and the presence of parenchymal abnormalities such as steatosis, fibrosis or chemotherapy-induced injuries (sinusoidal obstruction syndrome, steatohepatitis) at the histological analysis of the non tumoral liver parenchyma.
• To assess the sensitivity of hepatobiliary scintigraphy in jaundiced patients who had a preoperative biliary endoscopic or radiologic drainage, considering the existing competition between mebrofenin and bilirubin on hepatic receptors.
• To analyse the inter-centre reproducibility of the hepatobiliary scintigraphy (Central review by the principal investigator of 25 scintigraphy examinations per centre)

Conditions

Hepatic Insufficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Extended hepatectomy

Hepatic Scintigraphy

Group Type: OTHER

Hepatobiliary scintigraphy

Intervention Type: DEVICE

hepatobiliary scintigraphy with functional assessment of the future remnant liver before an extended hepatectomy of 4 or more segments

Interventions

Hepatobiliary scintigraphy

hepatobiliary scintigraphy with functional assessment of the future remnant liver before an extended hepatectomy of 4 or more segments

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Noncirrhotic liver
• Benign or malignant liver tumor
• Anatomic hepatic resection ≥ 4 segments
• Aged ≥18
• ASA Score ≤3
• Signed informed consent
• Presence of contraception in non-menopausal women

Exclusion Criteria

• Cirrhosis
• Absence of preoperative biliary drainage in case of preoperative jaundice
• Patient refusal
• Absence of affiliation to Social Security
• Body weight above 230kg
• Known allergy to Hida derivatives

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

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stéphanie Truant, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Hôpital Nord, CHU

Amiens, , France

CHU

Bordeaux, , France

Hopital Estaing - Chu63 - Clermont Ferrand

Clermont-Ferrand, , France

CHU

Grenoble, , France

CHRU, Hôpital Claude Huriez

Lille, , France

Centre Leon Berard - Lyon 08

Lyon, , France

Hopital Croix-Rousse - Hcl - Lyon 04

Lyon, , France

CHU

Marseille, , France

Chru Nancy - Hopitaux de Brabois

Nancy, , France

AP-HPHôpital Beaujon,

Paris, , France

CHU

Rouen, , France

CHU

Toulouse, , France

Countries

France

References

Bennink RJ, Tulchinsky M, de Graaf W, Kadry Z, van Gulik TM. Liver function testing with nuclear medicine techniques is coming of age. Semin Nucl Med. 2012 Mar;42(2):124-37. doi: 10.1053/j.semnuclmed.2011.10.003.

Reference Type: RESULT

PMID: 22293167 (View on PubMed)

de Graaf W, Heger M, Spruijt O, Maas A, de Bruin K, Hoekstra R, Bennink RJ, van Gulik TM. Quantitative assessment of liver function after ischemia-reperfusion injury and partial hepatectomy in rats. J Surg Res. 2012 Jan;172(1):85-94. doi: 10.1016/j.jss.2010.06.038. Epub 2010 Jul 21.

Reference Type: RESULT

PMID: 20869070 (View on PubMed)

de Graaf W, Bennink RJ, Vetelainen R, van Gulik TM. Nuclear imaging techniques for the assessment of hepatic function in liver surgery and transplantation. J Nucl Med. 2010 May;51(5):742-52. doi: 10.2967/jnumed.109.069435. Epub 2010 Apr 15.

Reference Type: RESULT

PMID: 20395336 (View on PubMed)

de Graaf W, Hausler S, Heger M, van Ginhoven TM, van Cappellen G, Bennink RJ, Kullak-Ublick GA, Hesselmann R, van Gulik TM, Stieger B. Transporters involved in the hepatic uptake of (99m)Tc-mebrofenin and indocyanine green. J Hepatol. 2011 Apr;54(4):738-45. doi: 10.1016/j.jhep.2010.07.047. Epub 2010 Oct 1.

Reference Type: RESULT

PMID: 21163547 (View on PubMed)

de Graaf W, van Lienden KP, van den Esschert JW, Bennink RJ, van Gulik TM. Increase in future remnant liver function after preoperative portal vein embolization. Br J Surg. 2011 Jun;98(6):825-34. doi: 10.1002/bjs.7456. Epub 2011 Apr 11.

Reference Type: RESULT

PMID: 21484773 (View on PubMed)

Other Identifiers

2014-A01685-42

Identifier Type: OTHER

Identifier Source: secondary_id

2014_02

Identifier Type: -

Identifier Source: org_study_id