BACKGROUND: EUS-guided pseudocyst drainage with fully covered self-expandable metal stents (FCSEMSs) was recently described. The appropriate period for stent removal is not known.
OBJECTIVE: To assess the safety and efficacy of EUS-guided FCSEMS placement for 3 weeks, along with pancreatic ductal stenting in selected patients.
STUDY DESIGN: Prospective, single-center evaluation.
SETTING: Tertiary referral center.
PATIENTS: Symptomatic pseudocysts in the body and tail region of the pancreas.
INTERVENTIONS: EUS-guided transgastric placement of FCSEMS. MRCP was performed after 3 weeks. Patients with a suspected pancreatic duct leak underwent ERCP and plastic stent placement. The FCSEMSs were removed at 3 weeks.
MAIN OUTCOME MEASUREMENTS: Success of FCSEMS placement, adverse events, and recurrence rate.
RESULTS: Forty-seven patients met the eligibility criteria. Technical and functional success was achieved in 43 patients (intention to treat, 91.48% and 95.34% patients [per protocol, 41/43, respectively]). Adverse events occurred in 2 patients (cyst infections, 4.6%). Follow-up of 42 patients at 3 weeks was performed. MRCP detected a ductal leak in 3 patients (7.1%) and a disconnected duct in 2 patients (4.7%). ERCP and stenting were successful in all 3 patients with a ductal leak. During a median follow-up of 306 days in 42 patients, 2 recurrences (4.7%) were detected, both in patients with disconnected duct. Multivariate analysis showed that pancreatic ductal leak or disconnection was an independent factor affecting pseudocyst resolution at 3 weeks (P = .0001).
LIMITATIONS: Single-center study.
CONCLUSION: Short-term placement of FCSEMSs with pancreatic ductal stenting in selected patients appears safe and effective for the treatment of pseudocysts.