Pancreas
Endoscopy. 2024;56(12):915-923
Biflanged metal stents versus plastic stents for endoscopic ultrasound-guided drainage of walled-off necrosis: A randomized controlled trial
Background: Endoscopic ultrasound (EUS)-guided drainage of walled-off necrosis (WON) using either plastic or metal stents is the mainstay of WON management. This single-center randomized controlled trial aimed to evaluate the efficacy of biflanged metal stents (BFMSs) and plastic stents for WON drainage.
Methods: Patients with symptomatic WON amenable to EUS-guided drainage were randomized to receive either BFMSs or plastic stents. The primary outcome was reintervention-free clinical success at 4 weeks. Secondary outcomes were: overall clinical success (complete resolution of symptoms and significant reduction in size of WON [< 50% of original size and < 5 cm in largest diameter at 4-week follow-up]); number of reinterventions; adverse events (AEs); hospital stay for first admission; and medium-term outcomes at 6 months (recurrence, disconnected pancreatic duct, chronic pancreatitis, and new-onset diabetes mellitus).
Results: 92 patients were randomized: 46 in each arm. The reintervention-free clinical success rate was significantly higher in the BFMS group on intention-to-treat analysis (67.4% vs. 43.5%; p = 0.02). Overall clinical success at 1 month was similar in both groups. There were significantly fewer reinterventions (median 0 [interquartile range, 0–1] vs. 1 [0–2]; p = 0.03) and shorter hospital stays in the BFMS group (7.0 [standard deviation, 3.4] vs. 9.1 [5.5] days; p = 0.04). There were no differences in procedure-related AEs, mortality, or medium-term outcomes.
Conclusions: Biflanged metal stents provide better reintervention-free clinical success at 4 weeks, with shorter hospital stay and without increased risks of adverse events, compared with plastic stents for endoscopic ultrasound-guided drainage of walled-off necrosis. Medium-term outcomes are however similar for both stent types.
DOI: 10.1055/a-2332-3448