title: Impact of biliary stent-related events in patients diagnosed with advanced pancreatobiliary tumours receiving palliative chemotherapy.
abstract: OBJECTIVE
  To determine the impact (morbidity/mortality) of biliary stent-related events (SRE) (cholangitis or stent obstruction) in chemotherapy-treated pancreatico-biliary patients.
  
  
  METHODS
  All consecutive patients with advanced pancreatobiliary cancer and a biliary stent in-situ prior to starting palliative chemotherapy were identified retrospectively from local electronic case-note records (Jan 13 to Jan 15). The primary end-point was SRE rate and the time-to-SRE (defined as time from first stenting before chemotherapy to date of SRE). Progression-free survival and overall survival were measured from the time of starting chemotherapy. Kaplan-Meier, Cox and Fine-Gray regression (univariate and multivariable) analyses were employed, as appropriate. For the analysis of time-to-SRE, death was considered as a competing event.
  
  
  RESULTS
  Ninety-six out of 693 screened patients were eligible; 89% had a metal stent (the remainder were plastic). The median time of follow-up was 9.6 mo (range 2.2 to 26.4). Forty-one patients (43%) developed a SRE during follow-up [cholangitis (39%), stent obstruction (29%), both (32%)]. There were no significant differences in baseline characteristics between the SRE group and no-SRE groups. Recorded SRE-consequences were: none (37%), chemotherapy delay (24%), discontinuation (17%) and death (22%). The median time-to-SRE was 4.4 mo (95%CI: 3.6-5.5). Patients with severe comorbidities (P < 0.001) and patients with ≥ 2 baseline stents/biliary procedures [HR = 2.3 (95%CI: 1.2-4.44), P = 0.010] had a shorter time-to-SRE on multivariable analysis. Stage was an independent prognostic factor for overall survival (P = 0.029) in the multivariable analysis adjusted for primary tumour site, performance status and development of SRE (SRE group vs no-SRE group).
  
  
  CONCLUSIONS
  SREs are common and impact on patient's morbidity. Our results highlight the need for prospective studies exploring the role of prophylactic strategies to prevent/delay SREs.
authors.affiliation: Angela Lamarca, Christina Rigby, Mairéad G McNamara, Richard A Hubner, Juan W Valle, Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester M20 4BX, Manchester, United Kingdom.
authors.forename: Angela
authors.initials: A
authors.lastname: Lamarca
authors.affiliation: Angela Lamarca, Christina Rigby, Mairéad G McNamara, Richard A Hubner, Juan W Valle, Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester M20 4BX, Manchester, United Kingdom.
authors.forename: Christina
authors.initials: C
authors.lastname: Rigby
authors.affiliation: Angela Lamarca, Christina Rigby, Mairéad G McNamara, Richard A Hubner, Juan W Valle, Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester M20 4BX, Manchester, United Kingdom.
authors.forename: Mairéad G
authors.initials: MG
authors.lastname: McNamara
authors.affiliation: Angela Lamarca, Christina Rigby, Mairéad G McNamara, Richard A Hubner, Juan W Valle, Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester M20 4BX, Manchester, United Kingdom.
authors.forename: Richard A
authors.initials: RA
authors.lastname: Hubner
authors.affiliation: Angela Lamarca, Christina Rigby, Mairéad G McNamara, Richard A Hubner, Juan W Valle, Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester M20 4BX, Manchester, United Kingdom.
authors.forename: Juan W
authors.initials: JW
authors.lastname: Valle
mesh_terms: D000230:Adenocarcinoma / Q000628:therapy*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000628:therapy*; D018281:Cholangiocarcinoma / Q000628:therapy*; D002758:Cholangiography; D002760:Cholangiopancreatography, Endoscopic Retrograde; D002761:Cholangitis / Q000209:etiology*; D002779:Cholestasis / Q000209:etiology*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D010166:Palliative Care; D010190:Pancreatic Neoplasms / Q000628:therapy*; D016016:Proportional Hazards Models; D012044:Regression Analysis; D012189:Retrospective Studies; D015607:Stents / Q000009:adverse effects*
chemical_list: D000970:Antineoplastic Agents
keywords: Advanced biliary tract cancer; Biliary obstruction; Biliary stent; Pancreatic cancer; Stent-related event