RESUMEN
On request from the Editors, the authors would like to clarify the following: the patient cohorts in the publications "No evidence of improved efficacy of covered stents over uncovered stents in percutaneous palliation of malignant hilar biliary obstruction: results of a prospective randomized trial".
RESUMEN
OBJECTIVE: To investigate whether covered stents show a higher efficacy than uncovered stents in percutaneous treatment of malignant hilar biliary obstruction. METHODS: Patients with obstructive jaundice caused by an unresectable hilar malignancy were included after failed endoscopic intervention in a prospective randomized trial comparing expanded polytetrafluoroethylene and fluorinated ethylene propylene (ePTFE-FEP)-covered nitinol stents with uncovered nitinol stents. Exclusion criteria were as follows: primary tumors existing more than 3 months, a biliodigestive anastomosis, previous stenting, and a Karnofsky score of less than 50. Safety, clinical success, and adjuvant chemotherapy were compared as well as occlusion rate, patency, and survival. RESULTS: A total of 120 patients were included. One patient was post hoc excluded. Fourteen patients who died within 7 days and one patient without patency data were excluded from patency analysis. Serious adverse events (p = 0.4), 30-day mortality (p = 0.5), and clinical success (p = 0.8) were equivalent for both stent groups. Twenty-one out of 61 (34%) patients in the covered and 24/58 (41%) in the uncovered stent groups received adjuvant chemotherapy (p = 0.5). Occlusion rate was 54% (27/50) in the covered stent group and 57% (31/54) in the uncovered stent group (p = 0.8). Median patency was 229 days (95% CI 113-345) for covered stents and 130 days (95% CI 75-185) for uncovered stents (p = 0.1). Median survival in patients with covered stents was 79 days (95% CI 52-106) and with uncovered stents 92 days (95% CI 60-124) (p = 0.3). CONCLUSION: In malignant hilar biliary obstruction, there is no evidence that ePTFE-FEP-covered stents are superior to uncovered stents in terms of safety, clinical success, adjuvant chemotherapy, patency, or survival. KEY POINTS: ⢠Percutaneous palliation of hilar biliary obstruction is feasible with both uncovered and covered stents. ⢠Clinical success in terms of bilirubin decrease and adjuvant chemotherapy is achievable with both stents. ⢠Thirty-day mortality is considerable when stenting is also offered to patients with a low performance status.
Asunto(s)
Procedimientos Quirúrgicos del Sistema Biliar/instrumentación , Colestasis/cirugía , Ictericia Obstructiva/cirugía , Neoplasias Hepáticas/terapia , Stents , Adulto , Anciano , Anciano de 80 o más Años , Colestasis/etiología , Colestasis/mortalidad , Materiales Biocompatibles Revestidos/uso terapéutico , Femenino , Humanos , Ictericia Obstructiva/etiología , Neoplasias Hepáticas/complicaciones , Neoplasias Hepáticas/mortalidad , Masculino , Persona de Mediana Edad , Cuidados Paliativos/métodos , Politetrafluoroetileno/análogos & derivados , Estudios Prospectivos , Stents/efectos adversosRESUMEN
BACKGROUND AND STUDY AIMS: Obstructive jaundice caused by metastatic disease leads to deterioration of general condition and short survival time. Successful decompression can offer symptom control and enable further treatment with chemotherapy, which can improve survival. PATIENTS AND METHODS: Ninety-nine percutaneous transhepatic cholangiography (PTC) procedures with metallic stent placement were performed in 93 patients between 2007 and 2013. Files were retrospectively studied and a review of patients' demographics, clinical and laboratory parameters, treatment and survival was performed. Kaplan-Meier survival analysis with log-rank test was done in function of bilirubin level, tumor type and treatment with chemotherapy. RESULTS: Hyperbilirubinemia resolved in 73% of procedures. Median survival time after the procedure was 48 (95%CI 34.8 - 61.1) days. If additional chemotherapy was possible, a median survival of 170 (95%CI 88.5 - 251.4) days was noted versus 32 (95%CI 22.4 - 41.5) days without chemotherapy (p < 0.01). Survival rates greatly differed between primary tumor type, with the largest benefit of PTC in colorectal cancer. In 35 % of the procedures minor or more severe complications were noted. The 30-day mortality was 33%, with 3 procedure related deaths. CONCLUSION: PTC with metallic stenting can bring symptom relief and enable further treatment with chemotherapy, which can lead to a longer survival time, especially in colorectal cancer. However, in patients in whom palliative stenting failed to resolve the hyperbilirubinemia survival is short.