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

被引：115

作者：

Loew, Burr J. ^{[1
]}

Howell, Douglas A. ^{[1
]}

Sanders, Michael K. ^{[1
]}

Desilets, David J. ^{[2
]}

Kortan, Paul P. ^{[3
]}

May, Gary R. ^{[3
]}

Shah, Raj J.

Chen, Yang K. ^{[4
]}

Parsons, Willis G. ^{[5
]}

Hawes, Robert H. ^{[6
]}

Cotton, Peter B. ^{[6
]}

Slivka, Adam A. ^{[7
]}

Ahmad, Jawad ^{[7
]}

Lehman, Glen A. ^{[8
]}

Sherman, Stuart ^{[8
]}

Neuhaus, Horst ^{[9
]}

Schumacher, Brigitte M. ^{[9
]}

机构：

[1] Maine Med Ctr, Portland, ME 04102 USA

[2] Baystate Med Ctr, Springfield, MA USA

[3] St Michaels Hosp, Toronto, ON M5B 1W8, Canada

[4] Univ Colorado, Hlth Sci Ctr, Denver, CO USA

[5] NW Mem Hosp, Chicago, IL 60611 USA

[6] Med Univ S Carolina, Charleston, SC 29425 USA

[7] Univ Pittsburgh, Med Ctr, Pittsburgh, PA USA

[8] Indiana Univ, Sch Med, Indianapolis, IN USA

[9] Evangel Krankenhaus, Dusseldorf, Germany

来源：

GASTROINTESTINAL ENDOSCOPY | 2009年 / 70卷 / 03期

关键词：

MALIGNANT OBSTRUCTIVE-JAUNDICE; COMMON BILE-DUCT; POLYETHYLENE STENTS; PANCREATIC-CANCER; TANNENBAUM TEFLON; PALLIATION; MANAGEMENT; WALLSTENT; COMPLICATIONS; STRICTURE;

D O I：

10.1016/j.gie.2008.11.018

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

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. (Gastrointest Endosc 2009;70:445-53.)

引用

页码：445 / 453

页数：9

共 26 条

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