RESUMEN
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.