Reversible Portal Vein Embolization Before Major Hepatectomy

Liver Regeneration Clinical Trial

— EMBORES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02945059
• Other study ID #: P150953
• Status: Completed
• Phase: N/A
• Start date: January 15, 2018
• Est. completion date: April 26, 2022

Study information

• Verified date: January 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 26, 2022
• Est. primary completion date: April 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Liver Regeneration
• Reversible Portal Vein Embolization

Intervention

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.

Locations

Country	Name	City	State
France	Antoine Béclère	Clamart

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Per and post procedure (within 6 weeks) morbidity	Portal thrombosis, pulmonary embolism and other complications	During PVE and within 6 weeks after embolization
Secondary	Liver tolerance	Liver function tests at Day0, Day1 and Day7 after portal vein embolization	At Day0, Day1 and Day7 after portal vein embolization
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	Intraoperative morbidity.	Liver failure and other complications due to surgery.	Up to 90 days following liver surgery.