학술논문
Plastic pigtail vs lumen-apposing metal stents for drainage of walled-off necrosis (PROMETHEUS study): an open-label, multicenter randomized trial
Document Type
Original Paper
Author
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; Vazquez-Sequeiros, Enrique
Source
Surgical Endoscopy: And Other Interventional Techniques. 38(4):2148-2159
Subject
Language
English
ISSN
0930-2794
1432-2218
1432-2218
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: