Comparative performance of uncoated, self-expanding metal biliary stents of different designs in 2 diameters: final results of an international multicenter, randomized, controlled trial

Burr J. Loew, Douglas A. Howell, Michael K. Sanders, David J. Desilets, Paul P. Kortan, Gary R. May, Raj J. Shah, Yang K. Chen, Willis G. Parsons, Robert H. Hawes, Peter B. Cotton, Adam A. Slivka, Jawad Ahmad, Glen A. Lehman, Stuart Sherman, Horst Neuhaus, Brigitte M. Schumacher

Research output: Contribution to journalArticle

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Abstract

Background: The Wallstent has remained the industry standard for biliary self-expanding metal stents (SEMSs). Recently, stents of differing designs, compositions, and diameters have been developed. Objective: To compare the new nitinol 6-mm and 10-mm Zilver stents with the 10-mm stainless steel Wallstent and determine the mechanism of obstruction. Design: Randomized, prospective, controlled study. Setting: Nine centers experienced in SEMS placement during ERCP. Patients: A total of 241 patients presenting between September 2003 and December 2005 with unresectable malignant biliary strictures at least 2 cm distal to the bifurcation. Main Outcome Measurement: Stent occlusions requiring reintervention and death. Results: At interim analysis, a significant increase in occlusions was noted in the 6-mm Zilver group at the P = .04 level, resulting in arm closure but continued follow-up. Final study arms were 64, 88, and 89 patients receiving a 6-mm Zilver, 10-mm Zilver, and 10-mm Wallstent, respectively. Stent occlusions occurred in 25 (39.1%) of the patients in the 6-mm Zilver arm, 21 (23.9%) of the patients in the 10-mm Zilver arm, and 19 (21.4%) of the patients in the 10-mm Wallstent arm (P = .02). The mean number of days of stent patency were 142.9, 185.8, and 186.7, respectively (P = .057). No differences were noted in secondary endpoints, and the study was ended at the 95% censored study endpoints. Biopsy specimens of ingrowth occlusive tissue revealed that 56% were caused by benign epithelial hyperplasia. Conclusions: SEMS occlusions were much more frequent with a 6-mm diameter SEMS and equivalent in the two 10-mm arms despite major differences in stent design, material, and expansion, suggesting that diameter is the critical feature. Malignant tumor ingrowth produced only a minority of the documented occlusions.

Original languageEnglish (US)
Pages (from-to)445-453
Number of pages9
JournalGastrointestinal endoscopy
Volume70
Issue number3
DOIs
StatePublished - Sep 1 2009

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Stents
Randomized Controlled Trials
Metals
Endoscopic Retrograde Cholangiopancreatography
Stainless Steel
Hyperplasia
Industry
Pathologic Constriction
Prospective Studies
Biopsy

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Gastroenterology

Cite this

Comparative performance of uncoated, self-expanding metal biliary stents of different designs in 2 diameters : final results of an international multicenter, randomized, controlled trial. / Loew, Burr J.; Howell, Douglas A.; Sanders, Michael K.; Desilets, David J.; Kortan, Paul P.; May, Gary R.; Shah, Raj J.; Chen, Yang K.; Parsons, Willis G.; Hawes, Robert H.; Cotton, Peter B.; Slivka, Adam A.; Ahmad, Jawad; Lehman, Glen A.; Sherman, Stuart; Neuhaus, Horst; Schumacher, Brigitte M.

In: Gastrointestinal endoscopy, Vol. 70, No. 3, 01.09.2009, p. 445-453.

Research output: Contribution to journalArticle

Loew, BJ, Howell, DA, Sanders, MK, Desilets, DJ, Kortan, PP, May, GR, Shah, RJ, Chen, YK, Parsons, WG, Hawes, RH, Cotton, PB, Slivka, AA, Ahmad, J, Lehman, GA, Sherman, S, Neuhaus, H & Schumacher, BM 2009, 'Comparative performance of uncoated, self-expanding metal biliary stents of different designs in 2 diameters: final results of an international multicenter, randomized, controlled trial', Gastrointestinal endoscopy, vol. 70, no. 3, pp. 445-453. https://doi.org/10.1016/j.gie.2008.11.018
Loew, Burr J. ; Howell, Douglas A. ; Sanders, Michael K. ; Desilets, David J. ; Kortan, Paul P. ; May, Gary R. ; Shah, Raj J. ; Chen, Yang K. ; Parsons, Willis G. ; Hawes, Robert H. ; Cotton, Peter B. ; Slivka, Adam A. ; Ahmad, Jawad ; Lehman, Glen A. ; Sherman, Stuart ; Neuhaus, Horst ; Schumacher, Brigitte M. / Comparative performance of uncoated, self-expanding metal biliary stents of different designs in 2 diameters : final results of an international multicenter, randomized, controlled trial. In: Gastrointestinal endoscopy. 2009 ; Vol. 70, No. 3. pp. 445-453.
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abstract = "Background: The Wallstent has remained the industry standard for biliary self-expanding metal stents (SEMSs). Recently, stents of differing designs, compositions, and diameters have been developed. Objective: To compare the new nitinol 6-mm and 10-mm Zilver stents with the 10-mm stainless steel Wallstent and determine the mechanism of obstruction. Design: Randomized, prospective, controlled study. Setting: Nine centers experienced in SEMS placement during ERCP. Patients: A total of 241 patients presenting between September 2003 and December 2005 with unresectable malignant biliary strictures at least 2 cm distal to the bifurcation. Main Outcome Measurement: Stent occlusions requiring reintervention and death. Results: At interim analysis, a significant increase in occlusions was noted in the 6-mm Zilver group at the P = .04 level, resulting in arm closure but continued follow-up. Final study arms were 64, 88, and 89 patients receiving a 6-mm Zilver, 10-mm Zilver, and 10-mm Wallstent, respectively. Stent occlusions occurred in 25 (39.1{\%}) of the patients in the 6-mm Zilver arm, 21 (23.9{\%}) of the patients in the 10-mm Zilver arm, and 19 (21.4{\%}) of the patients in the 10-mm Wallstent arm (P = .02). The mean number of days of stent patency were 142.9, 185.8, and 186.7, respectively (P = .057). No differences were noted in secondary endpoints, and the study was ended at the 95{\%} censored study endpoints. Biopsy specimens of ingrowth occlusive tissue revealed that 56{\%} were caused by benign epithelial hyperplasia. Conclusions: SEMS occlusions were much more frequent with a 6-mm diameter SEMS and equivalent in the two 10-mm arms despite major differences in stent design, material, and expansion, suggesting that diameter is the critical feature. Malignant tumor ingrowth produced only a minority of the documented occlusions.",
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T2 - final results of an international multicenter, randomized, controlled trial

AU - Loew, Burr J.

AU - Howell, Douglas A.

AU - Sanders, Michael K.

AU - Desilets, David J.

AU - Kortan, Paul P.

AU - May, Gary R.

AU - Shah, Raj J.

AU - Chen, Yang K.

AU - Parsons, Willis G.

AU - Hawes, Robert H.

AU - Cotton, Peter B.

AU - Slivka, Adam A.

AU - Ahmad, Jawad

AU - Lehman, Glen A.

AU - Sherman, Stuart

AU - Neuhaus, Horst

AU - Schumacher, Brigitte M.

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N2 - Background: The Wallstent has remained the industry standard for biliary self-expanding metal stents (SEMSs). Recently, stents of differing designs, compositions, and diameters have been developed. Objective: To compare the new nitinol 6-mm and 10-mm Zilver stents with the 10-mm stainless steel Wallstent and determine the mechanism of obstruction. Design: Randomized, prospective, controlled study. Setting: Nine centers experienced in SEMS placement during ERCP. Patients: A total of 241 patients presenting between September 2003 and December 2005 with unresectable malignant biliary strictures at least 2 cm distal to the bifurcation. Main Outcome Measurement: Stent occlusions requiring reintervention and death. Results: At interim analysis, a significant increase in occlusions was noted in the 6-mm Zilver group at the P = .04 level, resulting in arm closure but continued follow-up. Final study arms were 64, 88, and 89 patients receiving a 6-mm Zilver, 10-mm Zilver, and 10-mm Wallstent, respectively. Stent occlusions occurred in 25 (39.1%) of the patients in the 6-mm Zilver arm, 21 (23.9%) of the patients in the 10-mm Zilver arm, and 19 (21.4%) of the patients in the 10-mm Wallstent arm (P = .02). The mean number of days of stent patency were 142.9, 185.8, and 186.7, respectively (P = .057). No differences were noted in secondary endpoints, and the study was ended at the 95% censored study endpoints. Biopsy specimens of ingrowth occlusive tissue revealed that 56% were caused by benign epithelial hyperplasia. Conclusions: SEMS occlusions were much more frequent with a 6-mm diameter SEMS and equivalent in the two 10-mm arms despite major differences in stent design, material, and expansion, suggesting that diameter is the critical feature. Malignant tumor ingrowth produced only a minority of the documented occlusions.

AB - Background: The Wallstent has remained the industry standard for biliary self-expanding metal stents (SEMSs). Recently, stents of differing designs, compositions, and diameters have been developed. Objective: To compare the new nitinol 6-mm and 10-mm Zilver stents with the 10-mm stainless steel Wallstent and determine the mechanism of obstruction. Design: Randomized, prospective, controlled study. Setting: Nine centers experienced in SEMS placement during ERCP. Patients: A total of 241 patients presenting between September 2003 and December 2005 with unresectable malignant biliary strictures at least 2 cm distal to the bifurcation. Main Outcome Measurement: Stent occlusions requiring reintervention and death. Results: At interim analysis, a significant increase in occlusions was noted in the 6-mm Zilver group at the P = .04 level, resulting in arm closure but continued follow-up. Final study arms were 64, 88, and 89 patients receiving a 6-mm Zilver, 10-mm Zilver, and 10-mm Wallstent, respectively. Stent occlusions occurred in 25 (39.1%) of the patients in the 6-mm Zilver arm, 21 (23.9%) of the patients in the 10-mm Zilver arm, and 19 (21.4%) of the patients in the 10-mm Wallstent arm (P = .02). The mean number of days of stent patency were 142.9, 185.8, and 186.7, respectively (P = .057). No differences were noted in secondary endpoints, and the study was ended at the 95% censored study endpoints. Biopsy specimens of ingrowth occlusive tissue revealed that 56% were caused by benign epithelial hyperplasia. Conclusions: SEMS occlusions were much more frequent with a 6-mm diameter SEMS and equivalent in the two 10-mm arms despite major differences in stent design, material, and expansion, suggesting that diameter is the critical feature. Malignant tumor ingrowth produced only a minority of the documented occlusions.

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