title: Higher quality of life after metal stent placement compared with plastic stent placement for malignant extrahepatic bile duct obstruction: a randomized controlled trial.
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 treated with a plastic stent or SEMS.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: aDepartment of Gastroenterology and Hepatology bJulius Center for Health Sciences and Primary Care, University Medical Center cDepartment of Gastroenterology and Hepatology, Diakonessen Hospital, Utrecht dDepartment of Gastroenterology and Hepatology, Rijnstate Hospital, Arnhem eDepartment of Gastroenterology and Hepatology, St Antonius Hospital, Nieuwegein fDepartment of Gastroenterology and Hepatology, Gelderse Vallei Hospital, Ede gDepartment of Gastroenterology and Hepatology, Zorg Groep Twente, Hengelo hDepartment of Gastroenterology and Hepatology, Meander Medical Center, Amersfoort iDepartment of Gastroenterology and Hepatology, Haga Hospital, Den Haag jDepartment of Gastroenterology and Hepatology, Canisius Wilhelmina Hospital, Nijmegen kDepartment of Gastroenterology and Hepatology, Albert Schweitzer Hospital, Dordrecht lDepartment of Gastroenterology and Hepatology, Medisch Spectrum Twente, Enschede mDepartment of Gastroenterology and Hepatology, Onze Lieve Vrouwe Gasthuis, Amsterdam nDepartment of Gastroenterology and Hepatology, Amphia Hospital, Breda oDepartment of Gastroenterology and Hepatology, VieCuri Hospital, Venlods pDepartment of Gastroenterology and Hepatology, Martini Hospital qDepartment of Gastroenterology and Hepatology, University Medical Center Groningen, Groningen rDepartment of Gastroenterology and Hepatology, Jeroen Bosch Hospital, Den Bosch sDepartment of Decision Analysis, Erasmus University Medical Center, Rotterdam, The Netherlands tDepartment of Gastroenterology and Hepatology, University Hospital Gasthuisberg, University of Leuven, Leuven, Belgium.
authors.forename: Daisy
authors.initials: D
authors.lastname: Walter
authors.forename: Petra G A
authors.initials: PG
authors.lastname: van Boeckel
authors.forename: Marcel J M
authors.initials: MJ
authors.lastname: Groenen
authors.forename: Bas L A M
authors.initials: BL
authors.lastname: Weusten
authors.forename: Ben J
authors.initials: BJ
authors.lastname: Witteman
authors.forename: Gi
authors.initials: G
authors.lastname: Tan
authors.forename: Menno A
authors.initials: MA
authors.lastname: Brink
authors.forename: Jan
authors.initials: J
authors.lastname: Nicolai
authors.forename: Adriaan C
authors.initials: AC
authors.lastname: Tan
authors.forename: Joyce
authors.initials: J
authors.lastname: Alderliesten
authors.forename: Niels G
authors.initials: NG
authors.lastname: Venneman
authors.forename: Wim
authors.initials: W
authors.lastname: Laleman
authors.forename: Jeroen M
authors.initials: JM
authors.lastname: Jansen
authors.forename: Alexander
authors.initials: A
authors.lastname: Bodelier
authors.forename: Frank L
authors.initials: FL
authors.lastname: Wolters
authors.forename: Laurens A
authors.initials: LA
authors.lastname: van der Waaij
authors.forename: Ronald
authors.initials: R
authors.lastname: Breumelhof
authors.forename: Frans T M
authors.initials: FT
authors.lastname: Peters
authors.forename: Robbert C H
authors.initials: RC
authors.lastname: Scheffer
authors.forename: Ewout W
authors.initials: EW
authors.lastname: Steyerberg
authors.forename: Anne M
authors.initials: AM
authors.lastname: May
authors.forename: Max
authors.initials: M
authors.lastname: Leenders
authors.forename: Meike M C
authors.initials: MM
authors.lastname: Hirdes
authors.forename: Frank P
authors.initials: FP
authors.lastname: Vleggaar
authors.forename: Peter D
authors.initials: PD
authors.lastname: Siersema
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000379:methods*; D001651:Cholestasis, Extrahepatic / Q000209:etiology / Q000601:surgery*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010166:Palliative Care; D010190:Pancreatic Neoplasms / Q000150:complications / Q000473:pathology; D010969:Plastics; D011788:Quality of Life; D000069322:Self Expandable Metallic Stents; D015607:Stents; D011795:Surveys and Questionnaires
chemical_list: D010969:Plastics