Multicenter study of plastic vs. self-expanding metal stents in endoscopic ultrasound-guided drainage of walled-off pancreatic necrosis - PROMETHEUS

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 ov...

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Detalhes bibliográficos
Autores: Gornals, Joan B.|||0000-0001-8857-3556, Perez-Miranda, Manuel, Vazquez-Sequeiros, Enrique, Vila, Juan, Esteban López-Jamar, José Miguel, Gonzalez-Huix, Ferran, Guarner-Argente, Carlos|||0000-0002-8180-1488, Sanchez-Yague, Andres, Teran, Alvaro, Bas-Cutrina, Francesc|||0000-0002-6621-4509, De La Serna, Carlos, De Paredes, Ana Garcia, Ballester, Raquel, Velasquez-Rodriguez, Julio, Salord, Silvia|||0000-0002-8978-0079, Tebé, Cristian|||0000-0003-2320-1385, Hereu, Pilar|||0000-0002-9191-8962, Videla, Sebastián|||0000-0001-5049-1379
Formato: artículo
Fecha de publicación:2019
País:España
Recursos:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:285816
Acesso em linha:https://ddd.uab.cat/record/285816
https://dx.doi.org/urn:doi:10.1186/s13063-019-3988-x
Access Level:acceso abierto
Palavra-chave:Endoscopic ultrasound
Lumen-apposing metal stent
Metal self-expanding stent
Plastic stent
Randomized clinical trial
Self-expanding metal stent
Trial
Walled-off necrosis
Descrição
Resumo: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.

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