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

Not Applicable

Terminated

• Conditions: Hepatic Insufficiency
• Interventions: Device: Hepatobiliary scintigraphy

• Registration Number: NCT02753517
• Lead Sponsor: University Hospital, Lille

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)

Study Timeline

• Study Start: 2015-12-08
• Study First Submitted: 2016-04-25
• Study First Submitted QC: 2016-04-25
• Study First Posted: 2016-04-28
• Primary Completion: 2021-12-10
• Study Completion: 2021-12-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 326

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Extended hepatectomy	Hepatobiliary scintigraphy	Hepatic Scintigraphy

Primary Outcome Measures

Name	Time	Method
Hepatic insufficiency	at 3 months	ISGLS criteria : a definition and grading by the International Study Group of Liver Surgery (ISGLS)of the Posthepatectomy liver failure:

Secondary Outcome Measures

Name	Time	Method
Duration of intensive care unit stay and of hospitalization	3 months	Duration of hospitalization
Histological analysis of the non tumoral liver parenchyma	at 3 months	correlation of liver parenchymal abnormalities with the results of scintigraphy
Postoperative morbi-mortality	at 3 months	Clavien-Dindo classification
Inter-centre reproducibility of the hepatobiliary scintigraphy	at 3 months	Central review by the principal investigator of 25 scintigraphy examinations per centre

Trial Locations

Locations (8)

AP-HPHôpital Beaujon,; 🇫🇷 Paris, France

Chru Nancy - Hopitaux de Brabois; 🇫🇷 Nancy, France

Centre Leon Berard - Lyon 08; 🇫🇷 Lyon, France

Hopital Croix-Rousse - Hcl - Lyon 04; 🇫🇷 Lyon, France

Hôpital Nord, CHU; 🇫🇷 Amiens, France

Hopital Estaing - Chu63 - Clermont Ferrand; 🇫🇷 Clermont-Ferrand, France

CHRU, Hôpital Claude Huriez; 🇫🇷 Lille, France

CHU; 🇫🇷 Toulouse, France