title: A non-randomized study in consecutive patients with postcholecystectomy refractory biliary leaks who were managed endoscopically with the use of multiple plastic stents or fully covered self-expandable metal stents (with videos).
abstract: BACKGROUND
  Endoscopic management of postcholecystectomy biliary leaks is widely accepted as the treatment of choice. However, refractory biliary leaks after a combination of biliary sphincterotomy and the placement of a large-bore (10F) plastic stent can occur, and the optimal rescue endotherapy for this situation is unclear.
  
  
  OBJECTIVE
  To compare the clinical effectiveness of the use of a fully covered self-expandable metal stent (FCSEMS) with the placement of multiple plastic stents (MPS) for the treatment of postcholecystectomy refractory biliary leaks.
  
  
  METHODS
  Prospective study.
  
  
  METHODS
  Two tertiary-care referral academic centers and one general district hospital.
  
  
  METHODS
  Forty consecutive patients with refractory biliary leaks who underwent endoscopic management.
  
  
  METHODS
  Temporary placement of MPS (n = 20) or FCSEMSs (n = 20).
  
  
  METHODS
  Clinical outcomes of endotherapy as well as the technical success, adverse events, need for reinterventions, and prognostic factors for clinical success.
  
  
  RESULTS
  Endotherapy was possible in all patients. After endotherapy, closure of the leak was accomplished in 13 patients (65%) who received MPS and in 20 patients (100%) who received FCSEMSs (P = .004). The Kaplan-Meier (log-rank) leak-free survival analysis showed a statistically significant difference between the 2 patient populations (χ(2) [1] = 8.30; P < .01) in favor of the FCSEMS group. Use of <3 plastic stents (P = .024), a plastic stent diameter <20F (P = .006), and a high-grade biliary leak (P = .015) were shown to be significant predictors of treatment failure with MPS. The 7 patients in whom placement of MPS failed were retreated with FCSEMSs, resulting in closure of the leaks in all cases.
  
  
  CONCLUSIONS
  Non-randomized design.
  
  
  CONCLUSIONS
  In our series, the results of the temporary placement of FCSEMSs for postcholecystectomy refractory biliary leaks were superior to those from the use of MPS. A randomized study is needed to confirm our results before further recommendations.
authors.affiliation: Center of Gastroenterology, Cuf Infante Santo Hospital-Nova Medical School/Faculty of Medical Sciences, Lisbon, Portugal; Department of Gastroenterology, Pulido Valente Hospital do Centro Hospitalar Lisboa Norte, Lisbon, Portugal; Department of Endoscopy, José Joaquim Fernandes Hospital da Unidade Local de Saúde do Baixo Alentejo, Beja, Portugal.
authors.forename: Jorge
authors.initials: J
authors.lastname: Canena
authors.affiliation: Center of Gastroenterology, Cuf Infante Santo Hospital-Nova Medical School/Faculty of Medical Sciences, Lisbon, Portugal.
authors.forename: Manuel
authors.initials: M
authors.lastname: Liberato
authors.affiliation: Department of Gastroenterology, Pulido Valente Hospital do Centro Hospitalar Lisboa Norte, Lisbon, Portugal.
authors.forename: Liliane
authors.initials: L
authors.lastname: Meireles
authors.affiliation: Department of Gastroenterology, Pulido Valente Hospital do Centro Hospitalar Lisboa Norte, Lisbon, Portugal.
authors.forename: Inês
authors.initials: I
authors.lastname: Marques
authors.affiliation: Department of Gastroenterology, Pulido Valente Hospital do Centro Hospitalar Lisboa Norte, Lisbon, Portugal.
authors.forename: Carlos
authors.initials: C
authors.lastname: Romão
authors.affiliation: Center of Gastroenterology, Cuf Infante Santo Hospital-Nova Medical School/Faculty of Medical Sciences, Lisbon, Portugal.
authors.forename: António Pereira
authors.initials: AP
authors.lastname: Coutinho
authors.affiliation: Department of Gastroenterology, Pulido Valente Hospital do Centro Hospitalar Lisboa Norte, Lisbon, Portugal.
authors.forename: Beatriz Costa
authors.initials: BC
authors.lastname: Neves
authors.affiliation: Curva de Gauss-Research, Training and Consulting, Canas de Senhorim, Portugal.
authors.forename: Pedro Mota
authors.initials: PM
authors.lastname: Veiga
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001660:Biliary Tract Diseases / Q000209:etiology / Q000628:therapy*; D002760:Cholangiopancreatography, Endoscopic Retrograde; D002763:Cholecystectomy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D057194:Intention to Treat Analysis; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000628:therapy*; D011446:Prospective Studies; D000069322:Self Expandable Metallic Stents; D015607:Stents; D016896:Treatment Outcome