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

Autor: A Terán, Enrique Vazquez-Sequeiros, Juan J. Vila, Manuel Perez-Miranda, Pilar Hereu, Carlos Guarner-Argente, José Miguel Esteban, Andres Sanchez-Yague, Cristian Tebé, Joan B. Gornals, Ferran González-Huix, Carlos De la Serna, Ana García García de Paredes, Raquel Ballester, Francesc Bas-Cutrina, Silvia Salord, Julio G. Velasquez-Rodriguez, Sebas Videla
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Endoscopic ultrasound
Male
Medicine (miscellaneous)
Trial
law.invention
Pròtesis de Stent
Walled-off necrosis
self-expanding metal stent
Endosonography
Tertiary Care Centers
Study Protocol
0302 clinical medicine
Randomized controlled trial
law
Clinical endpoint
Medicine
Pharmacology (medical)
Prospective Studies
Aged
80 and over
lcsh:R5-920
medicine.diagnostic_test
Pancreatitis
Acute Necrotizing
Standard treatment
Middle Aged
Necrosi
Treatment Outcome
030220 oncology & carcinogenesis
Drainage
030211 gastroenterology & hepatology
Female
Randomized clinical trial
lcsh:Medicine (General)
Plastics
Adult
Transmural drainage
medicine.medical_specialty
Adolescent
Self Expandable Metallic Stents
Metal self-expanding stent
self-expanding metal stent
Lumen-apposing metal stent
03 medical and health sciences
Necrosis
Young Adult
Walled-off necrosis
Humans
Endoscòpia
Aged
Protocol (science)
business.industry
Endoscopy
Surgery
Clinical trial
Multicenter study
Pancreatitis
Spain
Plastic stent
business
Stents (Surgery)
Follow-Up Studies
Zdroj: Trials
r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
instname
Trials, Vol 20, Iss 1, Pp 1-10 (2019)
Dipòsit Digital de la UB
Universidad de Barcelona
ISSN: 1745-6215
Popis: Background 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. Methods/design 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 Discussion The PROMETHEUS trial has been designed to determine whether LAMS are superior to plastic stents in EUS-guided transmural drainage of WON. Trial registration ClinicalTrials.gov, ID: NCT03100578. Registered on 4 April 2017. https://clinicaltrials.gov/ct2/home
Databáze: OpenAIRE
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