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.
RCT Entities:
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.
Authors: Joseph Shatzel; Jisoo Kim; Kartik Sampath; Sharjeel Syed; Jennifer Saad; Zilla H Hussain; Kabir Mody; J Marc Pipas; Stuart Gordon; Timothy Gardner; Richard I Rothstein Journal: World J Gastrointest Endosc Date: 2016-01-25
Authors: Reem Z Sharaiha; Amrita Sethi; Kristen R Weaver; Tamas A Gonda; Raj J Shah; Norio Fukami; Prashant Kedia; Nikhil A Kumta; Carlos M Rondon Clavo; Michael D Saunders; Jorge Cerecedo-Rodriguez; Paola Figueroa Barojas; Jessica L Widmer; Monica Gaidhane; William R Brugge; Michel Kahaleh Journal: Dig Dis Sci Date: 2015-02-21 Impact factor: 3.199
Authors: Xi Feng; Madhava Pai; Malkhaz Mizandari; Tinatin Chikovani; Duncan Spalding; Long Jiao; Nagy Habib Journal: Front Med Date: 2011-10-02 Impact factor: 4.592
Authors: Reem Z Sharaiha; Nikola Natov; Kati S Glockenberg; Jessica Widmer; Monica Gaidhane; Michel Kahaleh Journal: Dig Dis Sci Date: 2014-07-18 Impact factor: 3.199