title: Safety and efficacy of endoscopic ultrasound-guided drainage of pancreatic fluid collections with lumen-apposing covered self-expanding metal stents.
abstract: OBJECTIVE
  Plastic stents, placed via endoscopy to drain pancreatic fluid collections (PFCs), require repeat access. Covered metal stents are larger in diameter and can be inserted in a single step, but can migrate. We evaluated the safety and efficacy of a lumen-apposing, covered, self-expanding metal stent (LACSEMS) for PFC drainage.
  
  
  METHODS
  We performed a prospective study of the outcomes of stent placement in 33 patients (18 men; age, 53 ± 14 y; 28 with chronic pancreatitis) with symptomatic pancreatic pseudocysts and walled-off necrosis (≥ 6 cm with ≥ 70% fluid content). Subjects were enrolled at 7 tertiary care centers (6 in the United States and 1 in Europe) from October 2011 through August 2013. Cystenterostomies were created based on endoscopist preference. Safety outcomes included infection, bleeding, perforation, tissue injury, and stent migration. Efficacy end points included LACSEMS placement, patency, and removal, as well as 50% or more reduction in PFCs.
  
  
  RESULTS
  The mean size of the patients' PFCs was 9 ± 3.3 cm. LACSEMSs were placed successfully via endoscopic ultrasound guidance in 30 patients (91%); the remaining 3 patients received 2 double-pigtail stents. One subject could not be evaluated because of a pseudoaneurysm. In the patients receiving LACSEMS, PFCs resolved in 27 of 29 (93%). Overall, PFCs resolved in 30 of 33 patients (91%). Endoscopic debridement through the LACSEMS was conducted in 11 subjects. Complications (15%) included abdominal pain (n = 3), spontaneous stent migration, back pain (n = 1), access-site infection, and stent dislodgement (n = 1).
  
  
  CONCLUSIONS
  LACSEMS were placed successfully in 91% of subjects with PFCs. Overall, 93% had PFC resolution. Advantages of LACSEMSs over other stents include single-step deployment and the ability to perform endoscopic debridement with minimal stent migration. Clinicaltrials.gov: NCT01419769.
authors.affiliation: Gastroenterology and Hepatology, University of Colorado Anschutz Medical Campus, Aurora, Colorado.
authors.forename: Raj J
authors.initials: RJ
authors.lastname: Shah
authors.affiliation: Interventional Endoscopy Services, California Pacific Medical Center, San Francisco, California.
authors.forename: Janak N
authors.initials: JN
authors.lastname: Shah
authors.affiliation: Center for Endoscopic Research and Therapeutics, The University of Chicago Medicine and Biological Sciences, Chicago, Illinois.
authors.forename: Irving
authors.initials: I
authors.lastname: Waxman
authors.affiliation: Gastroenterology and Hepatology, Thomas Jefferson University, Philadelphia, Pennsylvania.
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Kowalski
authors.affiliation: Gastroenterology & Hepatology, Hospital Costa del Sol, Marbella, Spain.
authors.forename: Andres
authors.initials: A
authors.lastname: Sanchez-Yague
authors.affiliation: Gastroenterology and Hepatology, Borland-Groover Clinic, Jacksonville, Florida.
authors.forename: Jose
authors.initials: J
authors.lastname: Nieto
authors.affiliation: Gastroenterology and Hepatology, University of Colorado Anschutz Medical Campus, Aurora, Colorado.
authors.forename: Brian C
authors.initials: BC
authors.lastname: Brauer
authors.affiliation: Gastroenterology and Hepatology, Weill Cornell Medical College, New York, New York.
authors.forename: Monica
authors.initials: M
authors.lastname: Gaidhane
authors.affiliation: Gastroenterology and Hepatology, Weill Cornell Medical College, New York, New York. Electronic address: mkahaleh@gmail.com.
authors.forename: Michel
authors.initials: M
authors.lastname: Kahaleh
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D004322:Drainage / Q000379:methods*; D004724:Endoscopy / Q000009:adverse effects* / Q000379:methods*; D019160:Endosonography / Q000009:adverse effects* / Q000379:methods*; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D008670:Metals / Q000009:adverse effects; D008875:Middle Aged; D010182:Pancreatic Diseases / Q000601:surgery; D010189:Pancreatic Juice; D011183:Postoperative Complications / Q000453:epidemiology; D011446:Prospective Studies; D015607:Stents / Q000009:adverse effects*; D062606:Tertiary Care Centers; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult
chemical_list: D008670:Metals
keywords: Axios; Clinical Trial; EUS; Pseudocyst Drainage