Plastic pigtail vs lumen-apposing metal stents for drainage of walled-off necrosis (PROMETHEUS study): an open-label, multicenter randomized trial.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
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, Spanish Working Group on Pancreatic Collection Therapy
Аннотация
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.