Antoine Béclère
Clamart, France
NCT Number: NCT02945059
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Clamart, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patient aged between 18 and 80 years
Exclusion criteria
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.
Time frame: 4-6 weeks after portal vein embolization
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:
The following formulas will be used to calculate hypertrophy ratio:
%FLR volume postPVE - %FLR volume prePVE
Time frame: During the procedure of portal vein embolization
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.
Time frame: During the procedure of portal vein embolization
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.
Time frame: During the procedure of portal vein embolization
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.
Time frame: During PVE and within 6 weeks after embolization
Portal thrombosis, pulmonary embolism and other complications
Time frame: At Day0, Day1 and Day7 after portal vein embolization
Liver function tests at Day0, Day1 and Day7 after portal vein embolization
Time frame: 4-6 weeks after portal vein embolization
During CT scan series performed 4 to 6 weeks after PVE, portal venous tree patency will be assessed by one independent blind observer.
Time frame: Through study completion, an average of 14 months
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.
Time frame: Through study completion, an average of 14 months
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.
Time frame: During liver surgery.
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.
Time frame: Up to 90 days following liver surgery.
Liver failure and other complications due to surgery.
Assistance Publique - Hôpitaux de Paris
Other
Multicentric Prospective Study Assessing the Efficiency of Preoperative Reversible Selective Portal Vein Embolization in Patients Requiring Major Hepatic Resection
Acronym: EMBORES
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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