RESUMO
BACKGROUND: A novel lumen-apposing, self-expanding metal stent to perform EUS-guided drainage procedures has been recently developed. The aim of this study was to analyze the safety, technical and clinical effectiveness of this device for EUS-guided choledochoduodenostomy (EUS-CD) with palliative intent. METHODS: Retrospective analysis of all consecutive patients with unresectable malignant distal bile duct obstruction who, between March 2012 and September 2014, underwent EUS-CD using the study devices (AXIOS™ and Hot AXIOS™, Xlumena Inc., Mountain View, CA, USA) after unsuccessful ERCP in seven European centers was carried out. RESULTS: Fifty-seven patients (M/F 31/26; median age 73) underwent EUS-CD using the AXIOS™ stent or the Hot AXIOS™ delivery system. ERCP failure was due to duodenal obstruction in 41 patients (71.9 %) and to inability to cannulate the papilla in the remaining 16 patients (28.1 %). The procedure was technically successful in 56/57 patients (98.2 %), with a mean procedural time of 22.4 min (range 11-65). Clinical success was achieved in 54 of these 56 patients (96.4 %; 94.7 % of the entire cohort). Overall major procedural complication rate was 7 % (two duodenal perforations, one bleeding and one transient cholangitis). During follow-up, 5 out of 54 (9.3 %) patients with clinica success required re-intervention for stent migration in one case and a sump syndrome with transient increase in serum bilirubin concentrations with sludge in the distal duct reservoir in the remaining four patients. CONCLUSIONS: Our study shows that EUS-CD using the AXIOS™ and the Hot AXIOS™ devices is a safe procedure, with high technical and clinical success rates.
Assuntos
Coledocostomia , Colestase/terapia , Materiais Revestidos Biocompatíveis , Endossonografia , Stents , Ultrassonografia de Intervenção , Idoso , Idoso de 80 Anos ou mais , Colangiopancreatografia Retrógrada Endoscópica/efeitos adversos , Colestase/etiologia , Dilatação , Drenagem/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/complicações , Estudos RetrospectivosRESUMO
BACKGROUND AND STUDY AIMS: A novel large-diameter, lumen-apposing, self-expanding metal stent with bilateral flanges was recently developed for endoscopic ultrasound (EUS)-guided transmural drainage of symptomatic pancreatic fluid collections (PFCs). The aim of this study was to evaluate the efficacy and safety of this stent in a large cohort. PATIENTS AND METHODS: Patients with a PFC undergoing EUS-guided drainage with this novel stent were prospectively enrolled in this multicenter cohort study. RESULTS: There were 61 patients: 46 patients (75â%) with walled-off necrosis (WON) and 15 (25â%) with a pancreatic pseudocyst. Stent placement was technically successful in 60 patients (98â%, 95â%CI 95â%â-â100â%). Clinical success, defined as resolution of clinical symptoms in combination with a decrease in the PFC size to ≤â2âcm on imaging, was achieved in 93â% of patients with a pancreatic pseudocyst (95â%CI 77â%â-â100â%) and in 81â% of patients with WON (95â%CI 69â%â-â94â%). Treatment failure occurred in nine patients (16â%, 95â%CI 6â%â-â26â%), including four patients who required surgical intervention. Stent removal was performed in 82â% of patients after a median of 32 days (range 2â-â178) and was rated as easy in all but one patient. In 10 patients, endoscopic stent removal was not performed because of stent migration (nâ=â3), stent dislodgement during necrosectomy (nâ=â3), stent removal during surgery (nâ=â2), or refusal by the patient (nâ=â2). In total, five major complications were reported (9â%, 95â%CI 2â%â-â16â%), including PFC infection (nâ=â4) and perforation (nâ=â1). CONCLUSION: EUS-guided drainage using this novel stent is feasible and the clinical results obtained are promising with a low major complication rate.