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

Eric Kullman; Farshad Frozanpor; Claes Soderlund; Stefan Linder; Per Sandstrom; Anna Lindhoff-Larsson; Ervin Toth; Gert Lindell; Eduard Jonas; Jacob Freedman; Martin Ljungman; Claes Rudberg; Bo Ohlin; Rebecka Zacharias; Carl-Eric Leijonmarck; Kalev Teder; Anders Ringman; Gunnar Persson; Mehmet Gozen; Olle Eriksson

doi:10.1016/j.gie.2010.07.036

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

Eric Kullman, Farshad Frozanpor, Claes Soderlund, Stefan Linder, Per Sandstrom, Anna Lindhoff-Larsson, Ervin Toth, Gert Lindell, Eduard Jonas, Jacob Freedman, Martin Ljungman, Claes Rudberg, Bo Ohlin, Rebecka Zacharias, Carl-Eric Leijonmarck, Kalev Teder, Anders Ringman, Gunnar Persson, Mehmet Gozen, Olle Eriksson

Research output: Chapter in Book/Report/Conference proceeding › Paper in conference proceeding › peer-review

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.)

Original language	English
Title of host publication	Gastrointestinal Endoscopy
Publisher	Elsevier
Pages	915-923
Volume	72
DOIs	https://doi.org/10.1016/j.gie.2010.07.036
Publication status	Published - 2010
Event	Digestive Disease Week/110th Annual Meeting of the American-Gastroenterological-Association - Chicago, IL Duration: 2009 May 30 → 2009 Jun 4

Publication series

Name
Number	5
Volume	72
ISSN (Print)	0016-5107

Conference

Conference	Digestive Disease Week/110th Annual Meeting of the American-Gastroenterological-Association
Period	2009/05/30 → 2009/06/04

Bibliographical note

The information about affiliations in this record was updated in December 2015.
The record was previously connected to the following departments: Surgery (Lund) (013009000), Emergency medicine/Medicine/Surgery (013240200)

Subject classification (UKÄ)

Surgery
Clinical Medicine

Access to Document

10.1016/j.gie.2010.07.036

Cite this

Kullman, E., Frozanpor, F., Soderlund, C., Linder, S., Sandstrom, P., Lindhoff-Larsson, A., Toth, E., Lindell, G., Jonas, E., Freedman, J., Ljungman, M., Rudberg, C., Ohlin, B., Zacharias, R., Leijonmarck, C.-E., Teder, K., Ringman, A., Persson, G., Gozen, M., & Eriksson, O. (2010). Covered versus uncovered self-expandable nitinol stents in the palliative treatment of malignant distal biliary obstruction: results from a randomized, multicenter study. In Gastrointestinal Endoscopy (Vol. 72, pp. 915-923). Elsevier. https://doi.org/10.1016/j.gie.2010.07.036

@inproceedings{01284e9b667f4b13b8f9e643d387e75d,

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

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 = "Eric Kullman and Farshad Frozanpor and Claes Soderlund and Stefan Linder and Per Sandstrom and Anna Lindhoff-Larsson and Ervin Toth and Gert Lindell and Eduard Jonas and Jacob Freedman and Martin Ljungman and Claes Rudberg and Bo Ohlin and Rebecka Zacharias and Carl-Eric Leijonmarck and Kalev Teder and Anders Ringman and Gunnar Persson and Mehmet Gozen and Olle Eriksson",

note = "The information about affiliations in this record was updated in December 2015. The record was previously connected to the following departments: Surgery (Lund) (013009000), Emergency medicine/Medicine/Surgery (013240200); Digestive Disease Week/110th Annual Meeting of the American-Gastroenterological-Association ; Conference date: 30-05-2009 Through 04-06-2009",

year = "2010",

doi = "10.1016/j.gie.2010.07.036",

language = "English",

volume = "72",

publisher = "Elsevier",

number = "5",

pages = "915--923",

booktitle = "Gastrointestinal Endoscopy",

address = "United States",

}

Kullman, E, Frozanpor, F, Soderlund, C, Linder, S, Sandstrom, P, Lindhoff-Larsson, A, Toth, E, Lindell, G, Jonas, E, Freedman, J, Ljungman, M, Rudberg, C, Ohlin, B, Zacharias, R, Leijonmarck, C-E, Teder, K, Ringman, A, Persson, G, Gozen, M & Eriksson, O 2010, Covered versus uncovered self-expandable nitinol stents in the palliative treatment of malignant distal biliary obstruction: results from a randomized, multicenter study. in Gastrointestinal Endoscopy. vol. 72, Elsevier, pp. 915-923, Digestive Disease Week/110th Annual Meeting of the American-Gastroenterological-Association, 2009/05/30. https://doi.org/10.1016/j.gie.2010.07.036

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 et al.
Gastrointestinal Endoscopy. Vol. 72 Elsevier, 2010. p. 915-923.

Research output: Chapter in Book/Report/Conference proceeding › Paper in conference proceeding › peer-review

TY - GEN

T1 - Covered versus uncovered self-expandable nitinol stents in the palliative treatment of malignant distal biliary obstruction: results from a randomized, multicenter study

AU - Kullman, Eric

AU - Frozanpor, Farshad

AU - Soderlund, Claes

AU - Linder, Stefan

AU - Sandstrom, Per

AU - Lindhoff-Larsson, Anna

AU - Toth, Ervin

AU - Lindell, Gert

AU - Jonas, Eduard

AU - Freedman, Jacob

AU - Ljungman, Martin

AU - Rudberg, Claes

AU - Ohlin, Bo

AU - Zacharias, Rebecka

AU - Leijonmarck, Carl-Eric

AU - Teder, Kalev

AU - Ringman, Anders

AU - Persson, Gunnar

AU - Gozen, Mehmet

AU - Eriksson, Olle

N1 - The information about affiliations in this record was updated in December 2015. The record was previously connected to the following departments: Surgery (Lund) (013009000), Emergency medicine/Medicine/Surgery (013240200)

PY - 2010

Y1 - 2010

N2 - 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.)

AB - 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.)

U2 - 10.1016/j.gie.2010.07.036

DO - 10.1016/j.gie.2010.07.036

M3 - Paper in conference proceeding

C2 - 21034892

VL - 72

SP - 915

EP - 923

BT - Gastrointestinal Endoscopy

PB - Elsevier

T2 - Digestive Disease Week/110th Annual Meeting of the American-Gastroenterological-Association

Y2 - 30 May 2009 through 4 June 2009

ER -

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

Abstract

Publication series

Conference

Bibliographical note

Subject classification (UKÄ)

Access to Document

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Cite this