title: Newly designed, fully covered metal stents for endoscopic ultrasound (EUS)-guided transmural drainage of peripancreatic fluid collections: a prospective randomized study.
abstract: OBJECTIVE
  Peripancreatic fluid collections (PFCs) have been adequately drained using multiple plastic stents placed in a single-step endoscopic ultrasound (EUS) procedure. Recent reports have presented the usefulness of metal stents for this procedure; however, there has been no prospective comparative study on their effectiveness and safety. We conducted a prospective randomized study to compare multiple plastic stents with fully covered, self-expanding metal stents (FCSEMSs) for the drainage of PFCs.
  
  
  METHODS
  Between January 2012 and May 2013, patients with PFCs demonstrated by various modalities were enrolled in our study. Patients were randomly assigned to receive either a FCSEMS or plastic stents for EUS-guided PFC drainage. The procedure time, technical success rate, and adverse event rates of the PFCs were evaluated.
  
  
  RESULTS
  50 patients (41 men) were included and randomly assigned to either the FCSEMS group (n = 25) or the plastic stent group (n = 25). The median procedure time with FCSEMS was significantly shorter than with plastic stents (15.0 min vs. 29.5 min, P < 0.01). The technical success rate was 100 % for both groups. The clinical success rate was 20 out of 23 for FCSEMS and 20 out of 22 for plastic stents (P = 0.97). No adverse events occurred in the FCSEMS group, while adverse events occurred in two patients in the plastic stent group (P = 0.16). One recurrence was observed during follow-up in the FCSEMS group and none in the plastic stent group (P = 0.15).
  
  
  CONCLUSIONS
  EUS-guided PFC drainage with FCSEMSs is comparable to such drainage with plastic stents in terms of technical feasibility, efficacy, and safety; however, the use of FCSEMSs may also simplify and shorten the procedure.
  
  
  BACKGROUND
  KCT0000766 (https://cris.nih.go.kr).
authors.affiliation: Department of Gastroenterology, University of Ulsan College of Medicine, Ulsan University Hospital, Ulsan, Korea.
authors.forename: Byung Uk
authors.initials: BU
authors.lastname: Lee
authors.affiliation: Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
authors.forename: Tae Jun
authors.initials: TJ
authors.lastname: Song
authors.affiliation: Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
authors.forename: Sang Soo
authors.initials: SS
authors.lastname: Lee
authors.affiliation: Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
authors.forename: Do Hyun
authors.initials: DH
authors.lastname: Park
authors.affiliation: Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
authors.forename: Dong-Wan
authors.initials: DW
authors.lastname: Seo
authors.affiliation: Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
authors.forename: Sung-Koo
authors.initials: SK
authors.lastname: Lee
authors.affiliation: Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
authors.forename: Myung-Hwan
authors.initials: MH
authors.lastname: Kim
mesh_terms: D001826:Body Fluids; D020099:Coated Materials, Biocompatible; D004322:Drainage / Q000379:methods*; D019160:Endosonography / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010182:Pancreatic Diseases / Q000000981:diagnostic imaging / Q000601:surgery*; D011446:Prospective Studies; D011474:Prosthesis Design; D016037:Single-Blind Method; D015607:Stents; D025321:Surgery, Computer-Assisted / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D020099:Coated Materials, Biocompatible