title: Endoscopic or percutaneous biliary drainage for gallbladder cancer: a randomized trial and quality of life assessment.
abstract: OBJECTIVE
  Patients with carcinoma of the gallbladder (GBC) and obstructive jaundice are usually not amenable to curative resection. Effective palliation by biliary decompression is the goal of treatment. Endoscopic stenting (ES) and percutaneous transhepatic biliary drainage (PTBD) can provide biliary decompression. We compared unilateral PTBD and ES in patients with a hilar block caused by GBC and assessed their quality of life (QOL).
  
  
  METHODS
  Consecutive patients with GBC not suitable for curative resection with Bismuth type 2 or 3 block were randomized to either PTBD or ES with a 10F plastic stent. Technical success, successful drainage, early cholangitis, complications, procedure-related mortality, 30-day mortality, survival, and QOL before and 1 and 3 months after stenting were compared between the 2 groups. All patients were followed up until death.
  
  
  RESULTS
  Fifty-four patients were randomized to PTBD or ES (27 each). Successful drainage was better in the PTBD group (89% vs 41%; P < .001). Early cholangitis was significantly higher in the ES group (48% vs 11%; P = .002). Procedure-related (4% vs 8%) and 30-day mortality (4% vs 8%) and median survival were similar (60 days in both; P = .71). Although the World Health Organization-Quality of Life 1- and 3-month physical and psychological scores were better after PTBD, the difference was not significant. The European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire 30 global health status at 3 months was significantly better after PTBD (75 vs 30.5, P = .02). The EORTC symptom scores improved in both groups, but only fatigue was significantly better after PTBD.
  
  
  CONCLUSIONS
  PTBD provides better biliary drainage and has lower complication rates in patients with GBC and hilar block.
authors.affiliation: Department of Gastrointestinal Surgery, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Sundeep Singh
authors.initials: SS
authors.lastname: Saluja
authors.forename: Manpreet
authors.initials: M
authors.lastname: Gulati
authors.forename: Pramod Kumar
authors.initials: PK
authors.lastname: Garg
authors.forename: Hemraj
authors.initials: H
authors.lastname: Pal
authors.forename: Sujoy
authors.initials: S
authors.lastname: Pal
authors.forename: Peush
authors.initials: P
authors.lastname: Sahni
authors.forename: Tushar K
authors.initials: TK
authors.lastname: Chattopadhyay
mesh_terms: D000328:Adult; D001662:Biliary Tract Surgical Procedures / Q000379:methods*; D004322:Drainage / Q000009:adverse effects / Q000379:methods*; D004724:Endoscopy / Q000009:adverse effects / Q000379:methods*; D005260:Female; D005706:Gallbladder Neoplasms / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D016019:Survival Analysis