Higher quality of life after metal stent placement compared with plastic stent placement for malignant extrahepatic bile duct obstruction: A randomized controlled trial
Walter, Daisy; Van Boeckel, Petra G A; Groenen, Marcel J M; Weusten, Bas L A M; Witteman, Ben J.; Tan, Gi; Brink, Menno A.; Nicolai, Jan; Tan, Adriaan C.; Alderliesten, Joyce; Venneman, Niels G.; Laleman, Wim; Jansen, Jeroen M.; Bodelier, Alexander; Wolters, Frank L.; Van Der Waaij, Laurens A.; Breumelhof, Ronald; Peters, Frans T M; Scheffer, Robbert C H; Steyerberg, Ewout W.; May, Anne M.; Leenders, Max; Hirdes, Meike M C; Vleggaar, Frank P.; Siersema, Peter D.
(2017) European Journal of Gastroenterology and Hepatology, volume 29, issue 2, pp. 231 - 237
(Article)
Abstract
Objective: For palliation of extrahepatic bile duct obstruction, self-expandable metal stents (SEMS) are superior to plastic stents in terms of stent patency and occurrence of stent dysfunction. We assessed health-related quality of life (HRQoL) after stent placement to investigate whether this also results in a difference in HRQoL between patients
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treated with a plastic stent or SEMS. Patients and methods: This randomized multicenter trial included 219 patients who were randomized to receive plastic stent (n =73) or SEMS [uncovered (n= 75) and covered (n =71); n =146] placement. HRQoL was assessed with two general questionnaires (EQ-5D-3L and QLQ-C30) and one disease-specific questionnaire (PAN-26). Scores were analyzed using linear mixed model regression and included all patients with baseline and at least one follow-up measurement. Results: HRQoL data were available in 140 of 219 patients (64%); 71 patients (32%) declined participation and in eight patients (4%) only baseline questionnaires were available. On the QLQ-C30, the interaction between follow-up time and type of stent was significantly different on two of five functional scales [physical functioning (P= 0.004) and emotional functioning (P =0.01)] in favor of patients with a SEMS. In addition, patients with SEMS reported significantly less frequent symptoms of fatigue (P =0.01), loss of appetite (P= 0.02), and nausea and vomiting (0.04) over time. The EQ-VAS score decreased with time in both treatment groups, indicating a statistically significant decrease in HRQoL over time. Conclusion: In patients with inoperable malignant extrahepatic bile duct obstruction, SEMS placement results in better scores for general and disease-specific HRQoL over time compared with plastic stent placement.
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Keywords: Bile ducts, Cholestasis, Palliative care, Quality of life, Stents, Hepatology, Gastroenterology, Journal Article, Comparative Study, Multicenter Study, Randomized Controlled Trial
ISSN: 0954-691X
Publisher: Lippincott Williams and Wilkins
Note: Publisher Copyright: Copyright © 2017 Wolters Kluwer Health, Inc. All rights reserved.
(Peer reviewed)