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

Hepatic Insufficiency Clinical Trial

— SCINTIVOL  

Official title:

Predictive Value of Hepato Biliary Scintigraphy to Assess the Risk of Postoperative Liver Failure Hepatectomies Stretches of 4 or More Segments on Non-cirrhotic Liver

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02753517
• Other study ID #: 2014_02
• Secondary ID: 2014-A01685-42
• Status: Recruiting
• Phase: N/A
• Start date: December 8, 2015
• Est. completion date: November 2023

Study information

• Verified date: November 2020
• Source: University Hospital, Lille
• Contact: Stéphanie Truant, MD
• Email: stephanie.truant[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: November 2023
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatic Insufficiency
• Liver Failure

Intervention

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

Locations

Country	Name	City	State
France	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

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (5)

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. Review. — View Citation

de Graaf W, Bennink RJ, Veteläinen 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. Review. — View Citation

de Graaf W, Häusler 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):738-4 — View Citation

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.20 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatic insufficiency	ISGLS criteria : a definition and grading by the International Study Group of Liver Surgery (ISGLS)of the Posthepatectomy liver failure:	at 3 months
Secondary	Postoperative morbi-mortality	Clavien-Dindo classification	at 3 months
Secondary	Duration of intensive care unit stay and of hospitalization	Duration of hospitalization	3 months
Secondary	Histological analysis of the non tumoral liver parenchyma	correlation of liver parenchymal abnormalities with the results of scintigraphy	at 3 months
Secondary	Inter-centre reproducibility of the hepatobiliary scintigraphy	Central review by the principal investigator of 25 scintigraphy examinations per centre	at 3 months