Clinical trial NCT02945059: Reversible Portal Vein Embolization Before Major Hepatectomy
Official title: Multicentric Prospective Study Assessing the Efficiency of Preoperative Reversible Selective Portal Vein Embolization in Patients Requiring Major Hepatic Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Regeneration
Reversible Portal Vein Embolization
Keywords: Liver regeneration
portal vein embolization
gelatin powder
liver surgery
hepatectomy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Reversible Portal vein embolization (PVE) using curaspon® (Absorbable Gelatin Hemostats)
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Hypertrophy ratio of FLR volume / total liver volume between the baseline and after the PVE
timeFrame: 4-6 weeks after portal vein embolization
Secondary outcomes:
measure: Technical feasibility: Percentage of completed PVE
timeFrame: During the procedure of portal vein embolization
measure: Technical feasibility: Percentage of partially completed PVE
timeFrame: During the procedure of portal vein embolization
measure: Technical feasibility: Percentage of not performed PVE
timeFrame: During the procedure of portal vein embolization
measure: Per and post procedure (within 6 weeks) morbidity
timeFrame: During PVE and within 6 weeks after embolization
measure: Liver tolerance
timeFrame: At Day0, Day1 and Day7 after portal vein embolization
measure: Rate of portal partial and complete recanalization (subsegmental, segmental and sectorial)
timeFrame: 4-6 weeks after portal vein embolization
measure: Rate of patients considered after portal vein embolization for surgery in their centers
timeFrame: Through study completion, an average of 14 months
measure: Rate of patients that finally undergo surgery
timeFrame: Through study completion, an average of 14 months
measure: Inflammation and adhesions during portal pedicles dissection
timeFrame: During liver surgery.
measure: Intraoperative morbidity.
timeFrame: Up to 90 days following liver surgery.
Other outcomes:
Locations:
city: Clamart
country: France
facility: Antoine Béclère
Study officials:
References: