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

被引:225
作者
Kullman, Eric [1 ]
Frozanpor, Farshad [2 ]
Soderlund, Claes [2 ]
Linder, Stefan [2 ]
Sandstrom, Per
Lindhoff-Larsson, Anna
Toth, Ervin [3 ]
Lindell, Gert [3 ]
Jonas, Eduard [4 ]
Freedman, Jacob [4 ]
Ljungman, Martin [5 ]
Rudberg, Claes [5 ]
Ohlin, Bo [6 ]
Zacharias, Rebecka [7 ]
Leijonmarck, Carl-Eric [7 ]
Teder, Kalev [8 ]
Ringman, Anders [8 ]
Persson, Gunnar [9 ]
Gozen, Mehmet [10 ]
Eriksson, Olle [11 ]
机构
[1] Linkoping Univ Hosp, Dept Surg, S-58185 Linkoping, Sweden
[2] Soder Sjukhuset, Stockholm, Sweden
[3] Univ Hosp MAS, Malmo, Sweden
[4] Danderyd Hosp, Stockholm, Sweden
[5] Cent Hosp Vasteras, Vasteras, Sweden
[6] Blekinge Hosp, Karlskrona, Sweden
[7] St Goran Hosp, Stockholm, Sweden
[8] Vrinnevi Hosp, Norrkoping, Sweden
[9] Ryhov Hosp, Jonkoping, Sweden
[10] Vastervik Hosp, Vastervik, Sweden
[11] Linkoping Univ, Linkoping, Sweden
关键词
EXPANDING METAL STENTS; COMMON BILE-DUCT; DIAMOND STENTS; POLYETHYLENE STENTS; CONTROLLED-TRIAL; MANAGEMENT; WALLSTENT; REMOVAL; COMPLICATIONS; CHOLECYSTITIS;
D O I
10.1016/j.gie.2010.07.036
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
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.)
引用
收藏
页码:915 / 923
页数:9
相关论文
共 45 条
[1]   Effectiveness of the ultraflex diamond stent for the palliation of malignant biliary obstruction [J].
Ahmad, J ;
Siqueira, E ;
Martin, J ;
Slivka, A .
ENDOSCOPY, 2002, 34 (10) :793-796
[2]  
[Anonymous], CARDIOVASC INTERVENT
[3]  
Arguedas MR, 2002, AM J GASTROENTEROL, V97, P898
[4]   SYMPTOM RELIEF AND QUALITY-OF-LIFE AFTER STENTING FOR MALIGNANT BILE-DUCT OBSTRUCTION [J].
BALLINGER, AB ;
MCHUGH, M ;
CATNACH, SM ;
ALSTEAD, EM ;
CLARK, ML .
GUT, 1994, 35 (04) :467-470
[5]   New ePTFE/FEP-covered stent in the palliative treatment of malignant biliary obstruction [J].
Bezzi, M ;
Zolovkins, A ;
Cantisani, V ;
Salvatori, FM ;
Rossi, M ;
Fanelli, F ;
Rossi, P .
JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY, 2002, 13 (06) :581-589
[6]   Uncovered Versus Covered Self-Expanding Metallic Stents for Inoperable Malignant Distal Biliary Obstruction: A Prospective Randomized Multicenter Study [J].
Cho, Young Deok ;
Cheon, Young Koog ;
Yoo, Kyo-Sang ;
Bang, Sung-Jo ;
Kim, Chang Duck ;
Kim, Jae Seon ;
Roh, Myung Hwan ;
Kim, Ho Gak .
GASTROINTESTINAL ENDOSCOPY, 2009, 69 (05) :AB137-AB137
[7]   ENDOSCOPIC SPHINCTEROTOMY COMPLICATIONS AND THEIR MANAGEMENT - AN ATTEMPT AT CONSENSUS [J].
COTTON, PB ;
LEHMAN, G ;
VENNES, J ;
GEENEN, JE ;
RUSSELL, RCG ;
MEYERS, WC ;
LIGUORY, C ;
NICKL, N .
GASTROINTESTINAL ENDOSCOPY, 1991, 37 (03) :383-393
[8]   RANDOMIZED TRIAL OF SELF-EXPANDING METAL STENTS VERSUS POLYETHYLENE STENTS FOR DISTAL MALIGNANT BILIARY OBSTRUCTION [J].
DAVIDS, PHP ;
GROEN, AK ;
RAUWS, EAJ ;
TYTGAT, GNJ ;
HUIBREGTSE, K .
LANCET, 1992, 340 (8834-5) :1488-1492
[9]  
Dumonceau JM, 2000, AM J GASTROENTEROL, V95, P670
[10]   Endoscopic removal of malfunctioning biliary self-expandable metallic stents [J].
Familiari, P ;
Bulajic, M ;
Mutignani, M ;
Lee, LS ;
Spera, G ;
Spada, C ;
Tringali, A ;
Costamagna, G .
GASTROINTESTINAL ENDOSCOPY, 2005, 62 (06) :903-910