NCT02945059

Reversible Portal Vein Embolization Before Major Hepatectomy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Regeneration
• Reversible Portal Vein Embolization

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-01-15
• Primary completion: 2022-04-26
• Completion: 2022-04-26
• First posted: 2016-10-26
• Last updated: 2024-01-24

Locations

1 site across 1 country: France