title: Randomized controlled trial of aspiration needle versus automated biopsy device for transjugular liver biopsy.
abstract: OBJECTIVE
  The efficacy and safety of transjugular liver biopsy used to obtain liver specimens in patients with coagulation disorders have been widely proven. However, histopathologic examination is not always possible because of fragmented samples provided by the aspiration technique. Recently, an automated device with a Tru-Cut-type needle was designed. In this randomized controlled trial, the use of this new device is compared with the traditional method in terms of efficacy and safety.
  
  
  METHODS
  Fifty-six patients were included in the study; 28 were randomized to undergo the aspiration technique and 28 were randomized to undergo the automated biopsy technique.
  
  
  RESULTS
  Correct positioning of the device was achieved in 93% of patients undergoing the aspiration technique and 96% of patients undergoing the automated biopsy technique (P = NS). Mean duration of the procedure and total number of passes were significantly higher in the aspiration needle group than in the automated device group (22.6 min +/- 12.6 vs 15.5 min +/- 9.4; P = .03, and 3.3 min +/- 1.9 vs 1.5 min +/- 0.63; P < .001, respectively). The number of portal tracts was significantly higher in the automated device group (4.7 +/- 2.5 vs. 2.7 +/- 3.4; P < .05). Adequate specimens for histopathologic evaluation were obtained in 26 patients in the automated device group and 24 patients in the aspiration needle group (92.8% vs 85.7%; P = NS), but a definite histopathologic diagnosis was more frequently obtained with the automated biopsy device (68% vs 43%; P = .05). No significant differences were observed in complication rates (7.14% vs. 10.7%; P = NS).
  
  
  CONCLUSIONS
  The automated biopsy device for transjugular liver biopsy is more effective than an aspiration needle in obtaining good samples for a definite histologic diagnosis.
authors.affiliation: Hepatic Hemodynamics Laboratory, Hospital General Universitario Gregorio Marañón, Universidad Complutense, Madrid, Spain. banares@inicia.es
authors.forename: R
authors.initials: R
authors.lastname: Bañares
authors.forename: S
authors.initials: S
authors.lastname: Alonso
authors.forename: M V
authors.initials: MV
authors.lastname: Catalina
authors.forename: M
authors.initials: M
authors.lastname: Casado
authors.forename: D
authors.initials: D
authors.lastname: Rincón
authors.forename: M
authors.initials: M
authors.lastname: Salcedo
authors.forename: E
authors.initials: E
authors.lastname: Alvarez
authors.forename: C
authors.initials: C
authors.lastname: Guerrero
authors.forename: A
authors.initials: A
authors.lastname: Echenagusía
authors.forename: F
authors.initials: F
authors.lastname: Camúñez
authors.forename: G
authors.initials: G
authors.lastname: Simó
mesh_terms: D000328:Adult; D001706:Biopsy / Q000295:instrumentation*; D001707:Biopsy, Needle / Q000295:instrumentation*; D001778:Blood Coagulation Disorders / Q000473:pathology; D005260:Female; D006801:Humans; D007601:Jugular Veins; D008099:Liver / Q000473:pathology*; D008107:Liver Diseases / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009339:Needles; D012449:Safety