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
Por:
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
Publicada:
30 dic 2019
Resumen:
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.
Filiaciones:
Gornals, JB:
Univ Barcelona, Hosp Univ Bellvitge, Bellvitge Biomed Res Inst IDIBELL, Dept Digest Dis,Endoscopy Unit, Feixa Llarga S-N, Barcelona 08907, Catalonia, Spain
Univ Oberta Catalunya, Hlth Sci, Barcelona, Spain
Perez-Miranda, M:
Hosp Univ Rio Hortega, Endoscopy Unit, Valladolid, Spain
Vazquez-Sequeiros, E:
Hosp Ramon & Cajal, Gastroenterol & Hepatol Serv, Endoscopy Unit, IRYCIS, Madrid, Spain
Vila, J:
Complejo Hosp Navarra, Endoscopy Unit, Pamplona, Spain
Esteban, JM:
Hosp Clin San Carlos, Dept Digest Dis, Endoscopy Unit, Madrid, Spain
Gonzalez-Huix, F:
Hosp Arnau Vilanova, Endoscopy Unit, Lleida, Spain
Guarner-Argente, C:
Hosp St Pau & Santa Creu, Endoscopy Unit, Barcelona, Spain
Sanchez-Yague, A:
Hosp Costa Sol, Endoscopy Unit, Marbella, Spain
Teran, A:
Hosp Univ Marques Valdecilla, Dept Digest Dis, Santander, Spain
Bas-Cutrina, F:
Univ Barcelona, Hosp Univ Bellvitge, Bellvitge Biomed Res Inst IDIBELL, Dept Digest Dis,Endoscopy Unit, Feixa Llarga S-N, Barcelona 08907, Catalonia, Spain
De La Serna, C:
Hosp Univ Rio Hortega, Endoscopy Unit, Valladolid, Spain
De Paredes, AG:
Hosp Ramon & Cajal, Gastroenterol & Hepatol Serv, Endoscopy Unit, IRYCIS, Madrid, Spain
Ballester, R:
Hosp Arnau Vilanova, Endoscopy Unit, Lleida, Spain
Velasquez-Rodriguez, J:
Univ Barcelona, Hosp Univ Bellvitge, Bellvitge Biomed Res Inst IDIBELL, Dept Digest Dis,Endoscopy Unit, Feixa Llarga S-N, Barcelona 08907, Catalonia, Spain
Salord, S:
Univ Barcelona, Hosp Univ Bellvitge, Bellvitge Biomed Res Inst IDIBELL, Hepatobilio Pancreat Unit,Dept Digest Dis, Barcelona, Spain
Tebe, C:
Inst Biomed Res Bellvitge, Biostat Unit, Barcelona, Spain
Hereu, P:
Univ Barcelona, Hosp Univ Bellvitge, Bellvitge Biomed Res Inst IDIBELL,Plataforma SCRe, Clin Res & Clin Trial Unit UICEC IDIBELL,Clin Pha, Barcelona, Catalonia, Spain
Videla, S:
Univ Barcelona, Hosp Univ Bellvitge, Bellvitge Biomed Res Inst IDIBELL,Plataforma SCRe, Clin Res & Clin Trial Unit UICEC IDIBELL,Clin Pha, Barcelona, Catalonia, Spain
Gold, Green Published
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