Author, as appears in the article.: Gornals JB, Perez-Miranda M, Vazquez-Sequeiros E, Vila J, Esteban JM, Gonzalez-Huix F, Guarner-Argente C, Sanchez-Yague A, Teran A, Bas-Cutrina F, De La Serna C, De Paredes AG, Ballester R, Velasquez-Rodriguez J, Salord S, Tebe C, Hereu P, Videla S, Spanish Working Group on Pancreatic Collection Therapy
Department: Ciències Mèdiques Bàsiques
URV's Author/s: TEBÉ CORDOMÍ, CRISTIAN
Keywords: Article Clinical Evaluation Clinical outcome Confidentiality Controlled Study Cost Benefit Analysis Endoscopic ultrasonography Endoscopic ultrasound Evidence Based Practice Follow Up Human Lumen-apposing metal stent Major Clinical Study Metal self-expanding stent Multicenter Study Operation Duration pancreas necrosis Patient Safety Plastic stent Prospective Study Randomized Clinical Trial Randomized Controlled Trial Recurrence Risk rescue work Retrospective Study Self-Expanding Metal Stent Spain Surgical Drainage Tertiary Care Center Treatment Withdrawal Trial walled off necrosis Walled-off necrosis Walled-off necrosis, self-expanding metal stent
Abstract: © 2019 The Author(s). 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 < 50% or < 5 cm in size), along with clinical improvement. Secondary endpoints: long-term (4 months) clinical success (total resolution or 5 cm), procedure duration, level of difficulty, safety, and recurrences. 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.
Thematic Areas: Medicine (Miscellaneous) Medicine, Research & Experimental Pharmacology (Medical)
licence for use: https://creativecommons.org/licenses/by/3.0/es/
Author's mail: cristian.tebe@urv.cat
ISSN: 17456215
Author identifier: 0000-0003-2320-1385
Record's date: 2020-08-07
Papper version: info:eu-repo/semantics/publishedVersion
Link to the original source: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3988-x
Papper original source: TRIALS. (ISSN/ISBN: 17456215). 20(1): 791
APA: Gornals J., Perez-Miranda M., Vazquez-Sequeiros E., Vila J., Esteban J., Gonzalez-Huix F., Guarner-Argente C., Sanchez-Yague A., Teran A., Bas-Cutrina F., De La Serna C., De Paredes A., Ballester R., Velasquez-Rodriguez J., Salord S., Tebe C., Hereu P., Videla S. (2020). 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. TRIALS, 20(1), 791-. DOI: 10.1186/s13063-019-3988-x
Licence document URL: https://repositori.urv.cat/ca/proteccio-de-dades/
Article's DOI: 10.1186/s13063-019-3988-x
Entity: Universitat Rovira i Virgili
Journal publication year: 2019
Publication Type: Journal Publications
Repositori URV