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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

  • Dades identificatives

    Identificador: imarina:6014308
    Autors:
    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
    Resum:
    © 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.
  • Altres:

    Autor segons l'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
    Departament: Ciències Mèdiques Bàsiques
    Autor/s de la URV: TEBÉ CORDOMÍ, CRISTIAN
    Paraules clau: 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
    Resum: © 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.
    Àrees temàtiques: Medicine (Miscellaneous) Medicine, Research & Experimental Pharmacology (Medical)
    Accès a la llicència d'ús: https://creativecommons.org/licenses/by/3.0/es/
    Adreça de correu electrònic de l'autor: cristian.tebe@urv.cat
    ISSN: 17456215
    Identificador de l'autor: 0000-0003-2320-1385
    Data d'alta del registre: 2020-08-07
    Versió de l'article dipositat: info:eu-repo/semantics/publishedVersion
    Enllaç font original: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3988-x
    Referència a l'article segons font original: TRIALS. (ISSN/ISBN: 17456215). 20(1): 791
    Referència de l'ítem segons les normes 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
    URL Document de llicència: https://repositori.urv.cat/ca/proteccio-de-dades/
    DOI de l'article: 10.1186/s13063-019-3988-x
    Entitat: Universitat Rovira i Virgili
    Any de publicació de la revista: 2019
    Tipus de publicació: Journal Publications
  • Paraules clau:

    Medicine (Miscellaneous),Medicine, Research & Experimental,Pharmacology (Medical)
    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
    Medicine (Miscellaneous)
    Medicine, Research & Experimental
    Pharmacology (Medical)
    17456215
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