Multicenter study of plastic vs. self-expanding metal stents in endoscopic ultrasound-guided drainage of walled-off pancreatic necrosis - PROMETHEUS : A randomized controlled trial protocol
Gornals, Joan B. (Hospital Universitari de Bellvitge)
Perez-Miranda, Manuel (Hospital Universitario Río Hortega (Valladolid))
Vazquez-Sequeiros, Enrique (Hospital Universitario Ramón y Cajal (Madrid))
Vila, Juan (Complejo Hospitalario de Navarra)
Esteban, José M. (Hospital Clínico San Carlos (Madrid))
Gonzalez-Huix, Ferran (Hospital Arnau de Vilanova (València))
Guarner-Argente, Carlos (Institut d'Investigació Biomèdica Sant Pau)
Sanchez-Yague, Andres (Hospital Costa Del Sol)
Teran, Alvaro (Hospital Universitario Marqués de Valdecilla (Santander, Cantabria))
Bas-Cutrina, Francesc (Hospital Universitari de Bellvitge)
De La Serna, Carlos (Hospital Universitario Río Hortega (Valladolid))
De Paredes, Ana Garcia (Hospital Universitario Ramón y Cajal (Madrid))
Ballester, Raquel (Hospital Arnau de Vilanova (València))
Velasquez-Rodriguez, Julio (Hospital Universitari de Bellvitge)
Salord, Silvia (Hospital Universitari de Bellvitge)
Tebé, Cristian (Hospital Universitari de Bellvitge)
Hereu, Pilar (Hospital Universitari de Bellvitge)
Videla, Sebastián (Hospital Universitari de Bellvitge)
Universitat Autònoma de Barcelona

Date:	2019
Abstract:	It seems that lumen-apposing metal stents (LAMS) are displacing plastic stents in the therapy of pancreatic-fluid collection in walled-off necrosis (WON). To date, there is no quality of evidence to recommend LAMS as the standard treatment in the management of WON. The theoretical benefit of LAMS over plastic stents needs to be proven. This is a randomized controlled, multicenter, prospective clinical trial with two parallel groups, without masking. One-hundred and fourteen patients with WON will undergo endoscopic ultrasound (EUS)-guided transmural draining in nine tertiary hospitals in Spain and will be randomized to the LAMS or plastic-stent group. The primary endpoint is the short-term (4 weeks) clinical success determined by the reduction of the collection (to < 50% or < 5 cm in size), along with clinical improvement. Long-term (4 months) clinical success (total resolution or 5 cm), procedure duration, level of difficulty, safety, and recurrences. The PROMETHEUS trial has been designed to determine whether LAMS are superior to plastic stents in EUS-guided transmural drainage of WON. ClinicalTrials. gov, ID: NCT03100578. Registered on 4 April 2017. https://clinicaltrials. gov/ct2/home.
Grants:	Ministerio de Economía y Competitividad PI15/00585
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Endoscopic ultrasound ; Lumen-apposing metal stent ; Metal self-expanding stent ; Plastic stent ; Randomized clinical trial ; Self-expanding metal stent ; Trial ; Walled-off necrosis
Published in:	Trials, Vol. 20 Núm. 1 (30 2019) , p. 791, ISSN 1745-6215

DOI: 10.1186/s13063-019-3988-x
PMID: 31888751

10 p, 590.7 KB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut de Recerca Sant Pau
Articles > Research articles
Articles > Published articles