Intraluminal brachytherapy of de novo TIPS: a prospective randomized double-blind study

The aim of this prospective double-blind and randomized study was to assess whether intraluminal brachytherapy of de novo transjugular intrahepatic portosystemic shunts (TIPS) can prevent significant shunt stenosis.

Forty patients with portal hypertension due to liver cirrhosis were enrolled. In the irradiation group of 20 patients, the gamma radiation source, iridium-192, was introduced into the shunt within a special balloon catheter that allows the radionuclide to be centered within the shunt. A dose of 14 Gy in the shunt wall at a depth of 2 mm should be achieved. In the control group of 20 patients, a dummy source was used. Doppler sonography was performed immediately, 1 day, 1 week, 4 weeks, and 3 months after TIPS placement and then at an interval of 3 months during the first year. The primary end point of the study was the percentage of patients who developed significant shunt stenosis, defined as a reduction of maximum flow velocity below 50 cm/sec in the proximal part of the shunt 1 cm from the entry of the stent into the punctured portal vein branch. Fisher's exact test was used.

The TIPS procedure was technically successful in all patients. Seventeen patients in the irradiation group and 15 patients in the control group were followed up. Five patients (29.4%) in the irradiation group and 10 (66.7%) in the control group developed significant shunt stenosis during the first year after TIPS placement (p = 0.0392). The time until such stenosis occurred did not differ significantly between the two groups.

Our results suggest that brachytherapy can be useful in reducing the incidence of TIPS stenosis. A larger study with histopathologic analysis may be needed to confirm these findings.