Objective: 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.
Subjects and methods: 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.
Results: 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.
Conclusion: 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.