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Randomized Controlled Trial
. 2024 Apr;38(4):2148-2159.
doi: 10.1007/s00464-024-10699-w. Epub 2024 Mar 6.

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

Joan B Gornals #  1   2   3 , Julio G Velasquez-Rodriguez #  4   5   6 , Francesc Bas-Cutrina  4   5   6 , Ana Garcia Garcia De Paredes  7   8 , Jose-Miguel Esteban  9 , Alvaro Teran  10 , Ferran Gonzalez-Huix  11 , Manuel Perez-Miranda  12 , Carlos Guarner-Argente  13 , Juan J Vila  14 , Albert Garcia-Sumalla  4   5   6 , Jose Ramon Foruny  7   8 , Joaquin Fisac-Vazquez  9 , Maria Moris  10 , Isabel Miquel-Salas  11 , Carlos De-la-Serna Higuera  12 , Marianette Murzi-Pulgar  13 , Andres Sanchez-Yague  15 , Silvia Salord  6   16 , Sandra Ruiz-Osuna  6   17 , Juli Busquets  6   18 , Mireia Sanllorente-Melenchon  6   19 , Sebas Videla  5   6   19   20 , Ramon Moreno  21 , Cristian Tebe-Cordomi  5   6   22 , Pilar Hereu  5   6   19   20 , Enrique Vazquez-Sequeiros  7   8 ; Spanish Working Group on Pancreatic Collection Therapy
Collaborators, Affiliations
Randomized Controlled Trial

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

Joan B Gornals et al. Surg Endosc. 2024 Apr.

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.

Keywords: Endoscopic ultrasound; Necrotizing pancreatitis; Randomized clinical trial; Therapeutic endoscopy; Transmural drainage.

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