Reversible Portal Vein Embolization Before Major Hepatectomy (EMBORES)

Multicentric Prospective Study Assessing the Efficiency of Preoperative Reversible Selective Portal Vein Embolization in Patients Requiring Major Hepatic Resection

The aim of this study is to prospectively evaluate the tolerance and efficiency of a new technique of preoperative selective portal vein embolization (PVE) in patients requiring major hepatic resection.

Study Overview

• Status: Completed
• Conditions: Liver Regeneration; Reversible Portal Vein Embolization
• Intervention / Treatment: Procedure: Selective reversible portal vein embolization

Detailed Description

Portal vein embolization (PVE) is used before major hepatectomy to induce hypertrophy of the future liver remnant (FLR). A non-reversible absorbable material is generally used for embolization, as it provides effective, permanent vascular occlusion. Our team has developed a minimally invasive technique of reversible PVE using gelfoam powder. The aim of this study is to assess the tolerance and efficiency of preoperative reversible selective PVE in patients requiring major hepatic resection. We hypothesize that preoperative reversible PVE allows to similarly increase FLR volume in comparison with classical non-reversible PVE in patients requiring major liver resection with limited FLR.

The hypertrophy ratio after classical non-reversible PVE is evaluated in literature as 13%. We estimated the hypertrophy ratio after reversible PVE as 9% in a previous retrospective study.

The aim of this pilot study is to prospectively evaluate the hypertrophy ratio after reversible PVE.

Primary End Point: Hypertrophy ratio of FLR volume / total liver volume between the baseline and after PVE, assessed by computed tomography scan volumetry 4-6 weeks after PVE.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clamart, France
    • Antoine Beclère

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Patient aged between 18 and 80 years

• Patient requiring major liver resection (at least 3 segments)
• PVE indication decided in a multidisciplinary meeting
• Patients who are able to understand and follow instructions and who are able to participate in the study for the entire period
• Patients must have given their written informed consent to participate in the study after having received adequate previous information and prior to any study-specific procedures
• Patient affiliated to the French National Social Security System

Exclusion Criteria:

• American Score of Anesthesiologist (ASA) > 3
• Extensive Portal vein or hepatic vein thrombosis
• Patient not covered by social security service
• Patient under guardianship
• Patients with a medical disorder, condition, or history of such that would impair the patient's ability to participate or complete this study in the opinion of the investigator.
• Patients who have already had anaphylactic or anaphylactoid reactions during the injection of iodinated contrast medium (edema of Quincke…)
• Patients with an allergy to pork products During the hospitalization and before the PVE
• Severe renal insufficiency (glomerular filtration rate ≤ 30mL/min eg calculated based on the Cockcroft formula).
• Pregnant women, or breast feeding women, or women with childbearing potential not using a combination of condoms and a safe and highly effective contraception method during the participation to the research (hormonal contraception with implants or oral contraceptives, or intrauterine devices).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Patients will undergo reversible PVE before major hepatic resection.	Procedure: Selective reversible portal vein embolization; Percutaneous access to the portal vein is achieved under general anesthesia with ultrasound or fluoroscopic control. After assessment of portal venous anatomy, embolization of selected portal vein segments is performed using the powdered form of an absorbable gelatin sponge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypertrophy ratio of FLR volume / total liver volume between the baseline and after the PVE	Ratio is evaluated by computed tomography scan volumetry 4-6 weeks after portal vein embolization.Volumes will be assessed by one independent blind observer, from anonymized CT scan series. Total, non-embolized (FLR) volume and embolized liver volume (ELV) will be measured. The following formulas will be used to calculate percentage of FLR volume: FLR volume prePVE = (FLR prePVE volume / (total liver prePVE volume - tumor volume prePVE)) x 100; FLR volume postPVE = (FLR postPVE volume / (total liver postPVE volume - tumor volume postPVE)) x 100 The following formulas will be used to calculate hypertrophy ratio: %FLR volume postPVE - %FLR volume prePVE	4-6 weeks after portal vein embolization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical feasibility: Percentage of completed PVE	Percutaneous access to the portal vein is achieved under general anesthesia with ultrasound or fluoroscopic control. Venous cartography of the liver is achieved with fluoroscopic control. PVE technique remains unchanged but a mixture of absorbable embolization agent is injected. Adverse events will be questioned and documented in the electronic Case Report Form.	During the procedure of portal vein embolization
Technical feasibility: Percentage of partially completed PVE	Percutaneous access to the portal vein is achieved under general anesthesia with ultrasound or fluoroscopic control. Venous cartography of the liver is achieved with fluoroscopic control. PVE technique remains unchanged but a mixture of absorbable embolization agent is injected. Adverse events will be questioned and documented in the electronic Case Report Form.	During the procedure of portal vein embolization
Technical feasibility: Percentage of not performed PVE	Percutaneous access to the portal vein is achieved under general anesthesia with ultrasound or fluoroscopic control. Venous cartography of the liver is achieved with fluoroscopic control. PVE technique remains unchanged but a mixture of absorbable embolization agent is injected. Adverse events will be questioned and documented in the electronic Case Report Form.	During the procedure of portal vein embolization
Per and post procedure (within 6 weeks) morbidity	Portal thrombosis, pulmonary embolism and other complications	During PVE and within 6 weeks after embolization
Liver tolerance	Liver function tests at Day0, Day1 and Day7 after portal vein embolization	At Day0, Day1 and Day7 after portal vein embolization
Rate of portal partial and complete recanalization (subsegmental, segmental and sectorial)	During CT scan series performed 4 to 6 weeks after PVE, portal venous tree patency will be assessed by one independent blind observer.	4-6 weeks after portal vein embolization
Rate of patients considered after portal vein embolization for surgery in their centers	All patients who underwent PVE procedure with sufficiently hypertrophy of non-embolized liver segments will return to hospital in order to undergo liver surgery. Decision to proceed with surgery will be left on investigator's discretion.	Through study completion, an average of 14 months
Rate of patients that finally undergo surgery	All patients who underwent PVE procedure with sufficiently hypertrophy of non-embolized liver segments will return to hospital in order to undergo liver surgery. Decision to proceed with surgery will be left on investigator's discretion.	Through study completion, an average of 14 months
Inflammation and adhesions during portal pedicles dissection	Assessment of the level of inflammation and adhesions will be performed during portal pedicles dissection. The senior surgeon will evaluate the level of inflammation and adhesions during portal pedicles dissection using a quantitative scale.	During liver surgery.
Intraoperative morbidity.	Liver failure and other complications due to surgery.	Up to 90 days following liver surgery.

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Actual): April 26, 2022
• Study Completion (Actual): April 26, 2022

Study Registration Dates

• First Submitted: October 17, 2016
• First Submitted That Met QC Criteria: October 24, 2016
• First Posted (Estimated): October 26, 2016

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: hepatectomy; liver surgery; Liver regeneration; portal vein embolization; gelatin powder
• Other Study ID Numbers: P150953

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No