Multicenter randomized trial of the spiral Z-stent compared with the Wallstent for malignant biliary obstruction

Raj J. Shah, Douglas A. Howell, David J. Desilets, Sunil G. Sheth, Willis G. Parsons, Patrick Okolo, Glen Lehman, Stuart Sherman, John Baillie, M. Stanley Branch, Douglas Pleskow, Ram Chuttani, John J. Bosco

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Abstract

Background: The industry standard since 1990 for self-expanding biliary metallic stents has been the Wallstent. In 1998 the Spiral Z-stent was released. This randomized trial compared the Z-stent with the Wallstent in the treatment of malignant biliary obstruction. Methods: Patients with unresectable malignant biliary obstruction distal to the bile duct bifurcation were randomized to receive a 10-mm diameter Wallstent or a 10-mm diameter Z-stent. Results: A total of 145 patients were randomized; 13 were excluded. Sixty-four patients who received a Z-stent and 68 who had a Wallstent are included in the analysis. Tumors responsible for bile duct obstruction were pancreatic cancer (108), cholangiocarcinoma (15), metastatic cancer (6), and papillary cancer (3). Metallic stents were successfully placed in all patients. Seven technical problems were encountered during placement of the Z-stent and 5 with the Wallstent. There were 21 occlusions requiring reintervention (8 Z-stent, 13 Wallstent; p = 0.30). Median time to reintervention was the following: Z-stent, 162 days; Wallstent, 150 days (p = 0.22). A total of 104 patients died of progressive disease or other cause; 7 patients remain alive with patent stents. The overall calculated median patency rates were: Z-stent, 152 days; Wallstent, 154 days (p = 0.90). Conclusions: The Spiral Z-stent is comparable with the Wallstent in terms of placement, occlusion rates, and overall patency. Occasional early occlusion of both stents suggests tumor characteristics instead of the size of the mesh openings in the stents as important factors. (Gastrointest Endosc 2003;57:830-6.).

Original languageEnglish (US)
Pages (from-to)830-836
Number of pages7
JournalGastrointestinal Endoscopy
Volume57
Issue number7
DOIs
StatePublished - Jun 2003
Externally publishedYes

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Multicenter Studies
Stents
Neoplasms
Cholangiocarcinoma
Cholestasis
Bile Ducts
Pancreatic Neoplasms
Industry

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Shah, R. J., Howell, D. A., Desilets, D. J., Sheth, S. G., Parsons, W. G., Okolo, P., ... Bosco, J. J. (2003). Multicenter randomized trial of the spiral Z-stent compared with the Wallstent for malignant biliary obstruction. Gastrointestinal Endoscopy, 57(7), 830-836. https://doi.org/10.1016/S0016-5107(03)70016-9

Multicenter randomized trial of the spiral Z-stent compared with the Wallstent for malignant biliary obstruction. / Shah, Raj J.; Howell, Douglas A.; Desilets, David J.; Sheth, Sunil G.; Parsons, Willis G.; Okolo, Patrick; Lehman, Glen; Sherman, Stuart; Baillie, John; Branch, M. Stanley; Pleskow, Douglas; Chuttani, Ram; Bosco, John J.

In: Gastrointestinal Endoscopy, Vol. 57, No. 7, 06.2003, p. 830-836.

Research output: Contribution to journalArticle

Shah, RJ, Howell, DA, Desilets, DJ, Sheth, SG, Parsons, WG, Okolo, P, Lehman, G, Sherman, S, Baillie, J, Branch, MS, Pleskow, D, Chuttani, R & Bosco, JJ 2003, 'Multicenter randomized trial of the spiral Z-stent compared with the Wallstent for malignant biliary obstruction', Gastrointestinal Endoscopy, vol. 57, no. 7, pp. 830-836. https://doi.org/10.1016/S0016-5107(03)70016-9
Shah, Raj J. ; Howell, Douglas A. ; Desilets, David J. ; Sheth, Sunil G. ; Parsons, Willis G. ; Okolo, Patrick ; Lehman, Glen ; Sherman, Stuart ; Baillie, John ; Branch, M. Stanley ; Pleskow, Douglas ; Chuttani, Ram ; Bosco, John J. / Multicenter randomized trial of the spiral Z-stent compared with the Wallstent for malignant biliary obstruction. In: Gastrointestinal Endoscopy. 2003 ; Vol. 57, No. 7. pp. 830-836.
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AU - Shah, Raj J.

AU - Howell, Douglas A.

AU - Desilets, David J.

AU - Sheth, Sunil G.

AU - Parsons, Willis G.

AU - Okolo, Patrick

AU - Lehman, Glen

AU - Sherman, Stuart

AU - Baillie, John

AU - Branch, M. Stanley

AU - Pleskow, Douglas

AU - Chuttani, Ram

AU - Bosco, John J.

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AB - Background: The industry standard since 1990 for self-expanding biliary metallic stents has been the Wallstent. In 1998 the Spiral Z-stent was released. This randomized trial compared the Z-stent with the Wallstent in the treatment of malignant biliary obstruction. Methods: Patients with unresectable malignant biliary obstruction distal to the bile duct bifurcation were randomized to receive a 10-mm diameter Wallstent or a 10-mm diameter Z-stent. Results: A total of 145 patients were randomized; 13 were excluded. Sixty-four patients who received a Z-stent and 68 who had a Wallstent are included in the analysis. Tumors responsible for bile duct obstruction were pancreatic cancer (108), cholangiocarcinoma (15), metastatic cancer (6), and papillary cancer (3). Metallic stents were successfully placed in all patients. Seven technical problems were encountered during placement of the Z-stent and 5 with the Wallstent. There were 21 occlusions requiring reintervention (8 Z-stent, 13 Wallstent; p = 0.30). Median time to reintervention was the following: Z-stent, 162 days; Wallstent, 150 days (p = 0.22). A total of 104 patients died of progressive disease or other cause; 7 patients remain alive with patent stents. The overall calculated median patency rates were: Z-stent, 152 days; Wallstent, 154 days (p = 0.90). Conclusions: The Spiral Z-stent is comparable with the Wallstent in terms of placement, occlusion rates, and overall patency. Occasional early occlusion of both stents suggests tumor characteristics instead of the size of the mesh openings in the stents as important factors. (Gastrointest Endosc 2003;57:830-6.).

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