1. Plastic pigtail vs lumen-apposing metal stents for drainage of walled-off necrosis (PROMETHEUS study): an open-label, multicenter randomized trial
- Author
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Gornals, Joan B., Velasquez-Rodriguez, Julio G., Bas-Cutrina, Francesc, Garcia Garcia De Paredes, Ana, Esteban, Jose-Miguel, Teran, Alvaro, Gonzalez-Huix, Ferran, Perez-Miranda, Manuel, Guarner-Argente, Carlos, Vila, Juan J., Garcia-Sumalla, Albert, Foruny, Jose Ramon, Fisac-Vazquez, Joaquin, Moris, Maria, Miquel-Salas, Isabel, De-la-Serna Higuera, Carlos, Murzi-Pulgar, Marianette, Sanchez-Yague, Andres, Salord, Silvia, Ruiz-Osuna, Sandra, Busquets, Juli, Sanllorente-Melenchon, Mireia, Videla, Sebas, Moreno, Ramon, Tebe-Cordomi, Cristian, Hereu, Pilar, and Vazquez-Sequeiros, Enrique
- Abstract
Background: Lumen-apposing metal stents (LAMS) have displaced double-pigtail plastic stents (DPS) as the standard treatment for walled-off necrosis (WON),β but evidence for exclusively using LAMS is limited. We aimed to assess whether the theoretical benefit of LAMS was superior to DPS. Methods: This multicenter, open-label, randomized trial was carried out in 9 tertiary hospitals. Between June 2017, and Oct 2020, we screened 99 patients with symptomatic WON, of whom 64 were enrolled and randomly assigned to the DPS group (n= 31) or the LAMS group (n= 33). The primary outcome was short-term (4-weeks) clinical success determined by the reduction of collection. Secondary endpoints included long-term clinical success, hospitalization, procedure duration, recurrence, safety, and costs. Analyses were by intention-to-treat. ClinicalTrials.gov, NCT03100578. Results: A similar clinical success rate in the short term (RR, 1.41; 95% CI 0.88–2.25; p= 0.218) and in the long term (RR, 1.2; 95% CI 0.92–1.58; p= 0.291) was observed between both groups. Procedure duration was significantly shorter in the LAMS group (35 vs. 45-min, p= 0.003). The hospital admission after the index procedure (median difference, − 10 [95% CI − 17.5, − 1]; p= 0.077) and global hospitalization (median difference − 4 [95% CI − 33, 25.51]; p= 0.82) were similar between both groups. Reported stent-related adverse events were similar for the two groups (36 vs.45% in LAMS vs. DPS), except for de novo fever, which was significantly 26% lower in LAMS (RR, 0.26 [0.08–0.83], p= 0.015). Conclusions: The clinical superiority of LAMS over DPS for WON therapy was not proved, with similar clinical success, hospital stay and similar safety profile between both groups, yet a significant reduction in procedure time was observed. Trial registration number: ClinicalTrials.gov, NCT03100578. Graphical abstract:
- Published
- 2024
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