title: Safety and efficacy of a new non-foreshortening nitinol stent in malignant gastric outlet obstruction (DUONITI study): a prospective, multicenter study.
abstract: OBJECTIVE
  Gastric outlet obstruction (GOO) is a late complication of advanced gastric, periampullary, and duodenal malignancies. Palliation of obstruction is the primary aim of treatment in these patients. Self-expandable metal stents have emerged as a promising treatment option. Our aim was to investigate the safety and efficacy of a new non-foreshortening nitinol duodenal stent.
  
  
  METHODS
  A total of 52 patients with symptomatic malignant GOO were studied in this prospective multicenter cohort study. All patients received a D-Weave Niti-S duodenal stent (Taewoong Medical, Seoul, South Korea). Patients were followed up until withdrawal of informed consent or death.
  
  
  RESULTS
  The cause of GOO was pancreatic cancer in the majority of patients (62%). The technical and clinical success rates were 96% and 77%, respectively. The GOO Scoring System score improved significantly (P < 0.0001) when the scores before stenting were compared with the mean scores until death. Median survival was 82 days and stent patency was observed in 75% for up to 190 days, accounting for death as a competing risk. In 13 patients (25%) stent dysfunction occurred (tumor ingrowth in 11, stent migration in two). Over time, the body mass index, the World Health Organization performance score, and the EuroQol visual analog scale revealed a not significant change (P = 0.52, P = 0.43, and P = 0.15, respectively), whereas the global health status improved significantly (P = 0.001).
  
  
  CONCLUSIONS
  Placement of a new non-foreshortening nitinol enteral stent is safe and without major complications. This stent design produces significant relief of obstructive symptoms and improves quality of life in patients with incurable malignant GOO.
authors.affiliation: Department of Gastroenterology and Hepatology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. J.E.vanhooft@amc.nl
authors.forename: J E
authors.initials: JE
authors.lastname: van Hooft
authors.forename: M L
authors.initials: ML
authors.lastname: van Montfoort
authors.forename: S M
authors.initials: SM
authors.lastname: Jeurnink
authors.forename: M J
authors.initials: MJ
authors.lastname: Bruno
authors.forename: M G
authors.initials: MG
authors.lastname: Dijkgraaf
authors.forename: P D
authors.initials: PD
authors.lastname: Siersema
authors.forename: P
authors.initials: P
authors.lastname: Fockens
mesh_terms: D000368:Aged; D000497:Alloys; D004067:Digestive System Neoplasms / Q000150:complications*; D005260:Female; D017219:Gastric Outlet Obstruction / Q000209:etiology* / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010166:Palliative Care; D011446:Prospective Studies; D011475:Prosthesis Failure; D011788:Quality of Life; D018709:Statistics, Nonparametric; D015607:Stents / Q000009:adverse effects
chemical_list: D000497:Alloys; C013616:nitinol