Estudio prospectivo randomizado para comparar la eficacia entre stents standards plásticos y de poliuretano en la obstrucción biliar maligna / Randomized prospective study to compare the efficiency between standard plastic stents and polyurethane stents in biliary tract malignant obstruction

ABSTRACT

The aim of this paper is to compare the efficiency between standard plastic stents and polyurethane stents used in biliary tract malignant obstruction. The main problem of the plastic prosthesis is their early occlusion. On the other hand there is the hypothesis that due to the less porousness of the polyurethane surface, there might be lesser adherence and consequently a late occlusion. Thirty-eight patients in two groups of 19 were evaluated prospectively and at random in the Jerusalem Hadassah Hospital and the HIGA San Martín La Plata. They had biliary tract obstruction due to inoperable tumors. Biliary endoprosthesis (plastic standard or polyurethane 10 French diameter) were placed, according to the randomization, after a previous staging with clinical examination, laboratory analysis and images. The follow-up with the same parameters was monthly done. Twelve of the 38 patients were female and 26 male; age average 62.73 (range 81-49). The stents were placed in 17 patients with biliary cancer, 14 pancreatic cancer, 2 papila cancer, 2 gallbladder cancer with bile duct invasion and 3 liver metastasis with biliary tract compression. The clinical and laboratory parameters in 36 patients at 30 days improved. On the contrary, 2 (1 plastic standard and 1 polyurethane stent) did not improve. There were 29 deaths due to the basic illness and not related to the endoscopic method. The mean obstruction occurred at 12.76 weeks (range 32-4) in the standard stents and 12.05 (range 24-2) in the polyurethane ones. CONCLUSION: There were no significant differences in the two groups patients.