N-butyl cyanoacrylate vs vascular plug and N-butyl cyanoacrylate combination as embolic agent for pre-operative portal vein embolization: A randomized controlled trial.

For many individuals with primary or metastatic liver tumors, the only treatment that offers a chance of cure is the surgical removal of part of the liver. Thanks to recent improvements in surgical methods and care after surgery, this major procedure can now be done with a relatively low risk of death. Nonetheless, the operation carries a significant risk of liver failure afterward, due to the substantial amount of liver tissue that is removed. To minimize this risk, evaluating the volume of the liver that will remain after surgery (known as the future liver remnant or FRL) is a crucial step in preparing patients for the procedure.

The goal of PVE is to promote contralateral hypertrophy by occluding portal vein branches on one side of the liver. However, the best embolic material for this procedure has yet to be determined. However, it is indicated that N-butyl cyanoacrylate (NBCA) may cause superior liver enlargement. This liquid embolic material has also been linked to quicker hypertrophy and less need for contrast material and radiation than other regularly utilized materials. Vascular plug and NBCA combination have been shown to be safe in avoiding non-target embolization and achieving adequate FLR hypertrophy. However, there has not been any randomized control trial to compare the efficacy in increasing the FLR volume by PVE with NBCA as compared to NBCA in combination with vascular plug. Our aims to establish the comparative efficacy and safety of the two embolic agents of PVE and contribute towards the understanding further.

The study will be conducted as a prospective randomized controlled  trail in the department of Radiodiagnosis in AIIMS Bhubaneswar. The hypothesis will be whether the combination of NBCA and a vascular plug more effective to using NBCA alone for promoting hypertrophy of future liver remnant after portal vein embolization prior to major liver resection. In the intervention group, patients will undergo portal vein  embolization using NBCA glue plus vascular plug combination. In the control group , patients will undergo portal vein  embolization using NBCA glue alone. The sample size would be 42(21 in each arm). The primary objective will be Assessment of absolute FLR hypertrophy at 14 days and 28 days after PVE. FLR absolute hypertrophy was calculated as (FLR volume after PVE-FLR volume before PVE) x 100/ (FLR volume before PVE).