Plastic pigtail vs lumen-apposing metal stents for drainage of walled-off necrosis (PROMETHEUS study): an open-label, multicenter randomized trial

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发表日期：

2024年3月6日

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Joan B. Gornals,
Julio G. Velasquez-Rodriguez,
Francesc Bas-Cutrina,
Ana Garcia Garcia De Paredes,
Jose-Miguel Esteban,
Alvaro Teran,
Ferran Gonzalez-Huix,
Manuel Perez-Miranda,
Carlos Guarner-Argente,
Juan J. Vila,
Albert Garcia-Sumalla,
Jose Ramon Foruny,
Joaquin Fisac-Vazquez,
Maria Moris,
Isabel Miquel-Salas,
Carlos De-la-Serna Higuera,
Marianette Murzi-Pulgar,
Andres Sanchez-Yague,
Silvia Salord,
Sandra Ruiz-Osuna,
Juli Busquets,
Mireia Sanllorente-Melenchon,
Sebas Videla,
Ramon Moreno,
Cristian Tebe-Cordomi,
Pilar Hereu,
Enrique Vazquez-Sequeiros,
Sergi Bazaga,
Claudia F. Consiglieri,
Manuel Vazquez-Romero,
Raquel Ballester,
Monica Domi,
David Leiva

摘要

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