Endoscopy · 2026
Top-down versus step-up approach after endoscopic ultrasound-guided drainage of infected walled-off necrosis: a randomized controlled trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Ancil Sanish, Shah Jimil, Jearth Vaneet, Singh Anupam K, Mandavdhare Harshal S, Sharma Vishal, Gupta Pankaj, Sarkaray Yashwant Raj, Singh Harjeet, Gupta Rajesh, Gkolfakis Paraskevas, Karstensen John Gásdal, Arvanitakis Marianna, Rana Surinder, Sinha Saroj K, Dutta Usha
Аннотация
BACKGROUND: The optimal timing and frequency of direct endoscopic necrosectomy (DEN) following endoscopic ultrasound (EUS)-guided drainage of infected walled-off necrosis (WON) remain unclear.
METHODS: This was a single-center, open-label randomized trial. Patients with proven or clinically suspected infected WON (>10 cm) with >30% solid debris were included. In the top-down group, DEN was performed during the index EUS-guided drainage session and repeated after 24 hours until complete clearance was achieved. In the step-up group, DEN was performed only in the presence of predefined clinical criteria after initial drainage. The primary end point was the number of reinterventions required to achieve clinical success. Secondary end points included new-onset organ failure, procedure-related adverse events, readmission, length of stay, and all-cause mortality.
RESULTS: Out of 208 patients screened during the study period, 54 patients were enrolled (27 per group). The median (IQR) number of reinterventions was lower in the top-down group (1 [2] vs. 2 [2]; P = 0.02), while the number of DENs (2 [1] vs. 1 [2]; P = 0.31) and overall procedure burden (4 [2] vs. 4 [2]; P = 0.95) were similar across both groups. Patients in the step-up group had higher readmission rates (44.4% vs. 18.5%; P = 0.04) and longer length of stay (12 [17] vs. 4 [8.5] days; P<0.001). New-onset organ failure, procedure-related adverse events (7.4% vs. 7.4%; P>0.99), and mortality (11.1% vs. 18.5%; P = 0.70) were similar across both groups.
CONCLUSION: In patients with infected WON and substantial solid debris, a top-down strategy was associated with shorter hospitalization and fewer readmissions with a similar overall procedural burden; however, readmission events may have been influenced by adjunctive strategy-related factors.
METHODS: This was a single-center, open-label randomized trial. Patients with proven or clinically suspected infected WON (>10 cm) with >30% solid debris were included. In the top-down group, DEN was performed during the index EUS-guided drainage session and repeated after 24 hours until complete clearance was achieved. In the step-up group, DEN was performed only in the presence of predefined clinical criteria after initial drainage. The primary end point was the number of reinterventions required to achieve clinical success. Secondary end points included new-onset organ failure, procedure-related adverse events, readmission, length of stay, and all-cause mortality.
RESULTS: Out of 208 patients screened during the study period, 54 patients were enrolled (27 per group). The median (IQR) number of reinterventions was lower in the top-down group (1 [2] vs. 2 [2]; P = 0.02), while the number of DENs (2 [1] vs. 1 [2]; P = 0.31) and overall procedure burden (4 [2] vs. 4 [2]; P = 0.95) were similar across both groups. Patients in the step-up group had higher readmission rates (44.4% vs. 18.5%; P = 0.04) and longer length of stay (12 [17] vs. 4 [8.5] days; P<0.001). New-onset organ failure, procedure-related adverse events (7.4% vs. 7.4%; P>0.99), and mortality (11.1% vs. 18.5%; P = 0.70) were similar across both groups.
CONCLUSION: In patients with infected WON and substantial solid debris, a top-down strategy was associated with shorter hospitalization and fewer readmissions with a similar overall procedural burden; however, readmission events may have been influenced by adjunctive strategy-related factors.