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Covered versus uncovered self-expandable nitinol stents in the palliative treatment of malignant distal biliary obstruction: results from a randomized, multicenter study

Kullman, Eric; Frozanpor, Farshad; Soderlund, Claes; Linder, Stefan; Sandstrom, Per; Lindhoff-Larsson, Anna; Toth, Ervin LU ; Lindell, Gert LU ; Jonas, Eduard and Freedman, Jacob, et al. (2010) Digestive Disease Week/110th Annual Meeting of the American-Gastroenterological-Association In Gastrointestinal Endoscopy 72(5). p.915-923
Abstract
Background: Covered biliary metal stents have been developed to prevent tumor ingrowth. Previous comparative studies are limited and often include few patients. Objective: To compare differences in stent patency, patient survival, and complication rates between covered and uncovered nitinol stents in patients with malignant biliary obstruction. Design: Randomized, multicenter trial conducted between January 2006 and October 2008. Setting: Ten sites serving a total catchment area of approximately 2.8 million inhabitants. Patients: A total of 400 patients with unresectable distal malignant biliary obstruction. Interventions: ERCP with insertion of covered or uncovered metal stent. Follow-up conducted monthly for symptoms indicating stent... (More)
Background: Covered biliary metal stents have been developed to prevent tumor ingrowth. Previous comparative studies are limited and often include few patients. Objective: To compare differences in stent patency, patient survival, and complication rates between covered and uncovered nitinol stents in patients with malignant biliary obstruction. Design: Randomized, multicenter trial conducted between January 2006 and October 2008. Setting: Ten sites serving a total catchment area of approximately 2.8 million inhabitants. Patients: A total of 400 patients with unresectable distal malignant biliary obstruction. Interventions: ERCP with insertion of covered or uncovered metal stent. Follow-up conducted monthly for symptoms indicating stent obstruction. Main Outcome Measurements: Time to stent failure, survival time, and complication rate. Results: The patient survival times were 116 days (interquartile range 242 days) and 174 days (interquartile range 284 days) in the covered and uncovered stent groups, respectively (P = .320). The first quartile stent patency time was 154 days in the covered stent group and 199 days in the uncovered stent group (P = .326). There was no difference in the incidence of pancreatitis or cholecystitis between the 2 groups. Stent migration occurred in 6 patients (3%) in the covered group and in no patients in the uncovered group (P = .030). Limitations: Randomization was not blinded. Conclusions: There were no significant differences in stent patency time, patient survival time, or complication rates between covered and uncovered nitinol metal stents in the palliative treatment of malignant distal biliary obstruction. However, covered stents migrated significantly more often compared with uncovered stents, and tumor ingrowth was more frequent in uncovered stents. (Clinical trial registration number: NCT00280709.) (Gastrointest Endosc 2010;72:915-23.) (Less)
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published
subject
in
Gastrointestinal Endoscopy
volume
72
issue
5
pages
915 - 923
publisher
Elsevier
conference name
Digestive Disease Week/110th Annual Meeting of the American-Gastroenterological-Association
external identifiers
  • wos:000284101500002
  • scopus:78049332929
ISSN
0016-5107
DOI
10.1016/j.gie.2010.07.036
language
English
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yes
id
01284e9b-667f-4b13-b8f9-e643d387e75d (old id 1753301)
date added to LUP
2010-12-29 13:45:02
date last changed
2018-07-01 03:58:59
@inproceedings{01284e9b-667f-4b13-b8f9-e643d387e75d,
  abstract     = {Background: Covered biliary metal stents have been developed to prevent tumor ingrowth. Previous comparative studies are limited and often include few patients. Objective: To compare differences in stent patency, patient survival, and complication rates between covered and uncovered nitinol stents in patients with malignant biliary obstruction. Design: Randomized, multicenter trial conducted between January 2006 and October 2008. Setting: Ten sites serving a total catchment area of approximately 2.8 million inhabitants. Patients: A total of 400 patients with unresectable distal malignant biliary obstruction. Interventions: ERCP with insertion of covered or uncovered metal stent. Follow-up conducted monthly for symptoms indicating stent obstruction. Main Outcome Measurements: Time to stent failure, survival time, and complication rate. Results: The patient survival times were 116 days (interquartile range 242 days) and 174 days (interquartile range 284 days) in the covered and uncovered stent groups, respectively (P = .320). The first quartile stent patency time was 154 days in the covered stent group and 199 days in the uncovered stent group (P = .326). There was no difference in the incidence of pancreatitis or cholecystitis between the 2 groups. Stent migration occurred in 6 patients (3%) in the covered group and in no patients in the uncovered group (P = .030). Limitations: Randomization was not blinded. Conclusions: There were no significant differences in stent patency time, patient survival time, or complication rates between covered and uncovered nitinol metal stents in the palliative treatment of malignant distal biliary obstruction. However, covered stents migrated significantly more often compared with uncovered stents, and tumor ingrowth was more frequent in uncovered stents. (Clinical trial registration number: NCT00280709.) (Gastrointest Endosc 2010;72:915-23.)},
  author       = {Kullman, Eric and Frozanpor, Farshad and Soderlund, Claes and Linder, Stefan and Sandstrom, Per and Lindhoff-Larsson, Anna and Toth, Ervin and Lindell, Gert and Jonas, Eduard and Freedman, Jacob and Ljungman, Martin and Rudberg, Claes and Ohlin, Bo and Zacharias, Rebecka and Leijonmarck, Carl-Eric and Teder, Kalev and Ringman, Anders and Persson, Gunnar and Gozen, Mehmet and Eriksson, Olle},
  booktitle    = {Gastrointestinal Endoscopy},
  issn         = {0016-5107},
  language     = {eng},
  number       = {5},
  pages        = {915--923},
  publisher    = {Elsevier},
  title        = {Covered versus uncovered self-expandable nitinol stents in the palliative treatment of malignant distal biliary obstruction: results from a randomized, multicenter study},
  url          = {http://dx.doi.org/10.1016/j.gie.2010.07.036},
  volume       = {72},
  year         = {2010},
}