Clinical-liver, pancreas, and biliary tractImproved clinical outcome using polytetrafluoroethylene-coated stents for tips: Results of a randomized study☆
Section snippets
Patients
To be included in the study, patients had to fulfill the following criteria: uncontrolled variceal bleeding; refractory ascites or recurrent variceal bleeding after failure of the usual pharmacological and endoscopic methods; presence of cirrhosis, as documented by previous liver biopsy or typical clinical signs; and age from 18 to 75 years. Exclusion criteria included a history of encephalopathy, portal vein thrombosis, hepatocellular carcinoma, cardiac failure, hepatic polycystosis, and
Population
Thirty-nine patients were randomly allocated to the e-PTFE-coated stent group (group 1) and 41 to the uncoated stent group (group 2). The main characteristics of the patients are presented in Table 1. The 2 groups differed only with respect to the diameter of the prosthesis (smaller in group 1). The median follow-up was 300 days (range, 1–832 days). One patient was lost to follow-up 7 days after TIPS. PPG was initially 20.1 ± 6.0 mm Hg and decreased to 6.9 ± 3.9 mm Hg after TIPS (P < 0.001).
Discussion
This study is the first randomized controlled trial comparing the rate of patency obtained with e-PTFE-coated stents and uncoated stents. The use of coated prostheses dramatically decreased the rate of shunt dysfunction. This was associated with a reduction of clinical relapses and the number of reinterventions. Contrary to expectations, the rate of encephalopathy was not increased, and the mean Child-Pugh score improved over time.
One of the main drawbacks of the TIPS procedure is the average
Acknowledgements
The authors thank Pr. L. Lareng and Dr. M. Savoldelli from the Institut Européen de Télémedecine, Pr. C. Mascotte for technical assistance, and Drs. J. M. Combis, A. Pariente, and K. Barange for referring patients.
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Supported by a grant from Programme Hospitalier de Recherche Clinique (97/63N) and from the Instituto de Salud Carlos III (CO3/02).