A Prospective Randomized Study of Hydrophilic Polymer-Coated Polyurethane Versus Polyethylene Stents in Distal Malignant Biliary Obstruction

Background and Study Aims: Hydrophilic polymer-coated polyurethane (HPCP) stents have a low friction coefficient and a hydrophilic layer, which may reduce biofilm formation and increase the period of stent patency. We compared the patency rates with this new stent with the standard Amsterdam-type polyethylene (PE) stent in a prospective randomized trial.
Patients and Methods: One hundred patients with an unresectable distal malignant bile duct stricture without a previous drainage procedure were randomly assigned to receive either a HPCP stent or a PE stent. The diameter (10 Fr), length (9 cm) and stent design (Amsterdam type) were similar in both stents. Nine patients were excluded. Forty-four patients received an HPCP stent and 47 patients a PE stent. The diagnoses included carcinoma of the pancreas (n = 78), papilla (n = 1), bile duct (n = 10), and metastases (n = 2).

Results: Stent insertion was successful in all patients. Stent dysfunction occurred in 27 of the HPCP stents and 20 of the PE stents, with median stent patency periods of 77 days (95 % CI, 53 - 101 days) for HPCP stents and 105 days (95 % CI, 42 - 168 days) for PE stents. The patency period was significantly longer for the PE stent (P = 0.04). Early complications occurred in four patients (4 %), one in the HPCP group and three in the PE group.
Conclusion: Hydrophilic polymer-coated polyurethane stents do not prolong the patency period of biliary stents. In fact, the current standard treatment using polyethylene stents in patients with distal malignant biliary obstruction showed a significantly longer patency period.

References

• 1 Jansen B, Goodman L P, Ruiten D. Bacterial adherence to hydrophilic polymer-coated polyurethane stents.  Gastrointest Endosc. 1993;  39 670-673
• 2 Costamagna G, Mutignani M, Rotondano G. et al . Hydrophilic hydromer-coated polyurethane stents versus uncoated stents in malignant biliary obstruction: a randomized trial.  Gastrointest Endosc. 2000;  51 8-11
• 3 Huibregtse K. Endoscopic biliary and pancreatic drainage. Stuttgart; Thieme 1988
• 4 Cotton P B, Lehman G, Vennes J. et al . Endoscopic sphincterotomy complications and their management: an attempt at consensus.  Gastrointest Endosc. 1991;  37 383-393
• 5 Speer A G, Cotton P B, MacRae K D. Endoscopic management of malignant biliary obstruction: stents of 10 French gauge are preferable to stents of 8 French gauge.  Gastrointest Endosc. 1988;  34 412-417
• 6 Leung J W, Ling T K, Kung J L, Vallance-Owen J. The role of bacteria in the blockage of biliary stents.  Gastrointest Endosc. 1988;  34 19-22
• 7 Coene P P, Groen A K, Cheng J. et al . Clogging of biliary endoprostheses: a new perspective.  Gut. 1990;  31 913-917
• 8 McAllister E W, Carey L C, Brady P G. et al . The role of polymeric surface smoothness of biliary stents in bacterial adherence, biofilm deposition, and stent occlusion.  Gastrointest Endosc. 1993;  39 422-425
• 9 Dowidar N, Kolmos H J, Matzen P. Experimental clogging of biliary endoprostheses: role of bacteria, endoprosthesis material, and design.  Scand J Gastroenterol. 1992;  27 77-80
• 10 Binmoeller K F, Seitz U, Seifert H. et al . The Tannenbaum stent: a new plastic biliary stent without side holes.  Am J Gastroenterol. 1995;  90 1764-1768
• 11 Seitz U, Vadeyar H, Soehendra N. Prolonged patency with a new-design Teflon biliary prosthesis.  Endoscopy. 1994;  26 478-482
• 12 Terruzzi V, Comin U, de Grazia F. et al . Prospective randomized trial comparing Tannenbaum Teflon and standard polyethylene stents in distal malignant biliary stenosis.  Gastrointest Endosc. 2000;  51 23-27
• 13 England R E, Martin D F, Morris J. et al . A prospective randomised multicentre trial comparing 10 Fr Teflon Tannenbaum stents with 10 Fr polyethylene Cotton-Leung stents in patients with malignant common duct strictures.  Gut. 2000;  46 395-400
• 14 Sung J J, Chung S C, Tsui C P. et al . Omitting side-holes in biliary stents does not improve drainage of the obstructed biliary system: a prospective randomized trial.  Gastrointest Endosc. 1994;  40 321-325
• 15 van Berkel A M, Boland C, Redekop W K. et al . A prospective randomized trial of Teflon versus polyethylene stents for distal malignant biliary obstruction.  Endoscopy. 1998;  30 681-686
• 16 van Berkel A M, van Marle J, van Veen H. et al . A scanning electron microscopic study of biliary stent materials.  Gastrointest Endosc. 2000;  51 19-22
• 17 Sung J Y, Shaffer E A, Lam K. et al . Hydrophobic bile salt inhibits bacterial adhesion on biliary stent material.  Dig Dis Sci. 1994;  39 999-1006