title: Endoscopic magnetic gastroenteric anastomosis for palliation of malignant gastric outlet obstruction: a prospective multicenter study.
abstract: BACKGROUND
  Palliation of malignant gastric outlet obstruction remains challenging. Although there are 2 established treatment options, ie, surgical gastrojejunostomy and endoscopic duodenal stent insertion, there is an ongoing search for a technique that would combine the safety and rapid effect of duodenal stent placement with the long-term efficacy and low reintervention rate of a surgical gastrojejunostomy.
  
  
  OBJECTIVE
  To investigate the safety and success rate of endoscopic creation of a gastroenteric anastomosis formed by magnetic compression and stent placement.
  
  
  METHODS
  Prospective, multicenter cohort study.
  
  
  METHODS
  Four referral centers.
  
  
  METHODS
  The expected number of patients with symptomatic malignant gastric outlet obstruction to be included at the participating hospitals during a year was 40. Because of a serious adverse device event, the study was terminated after inclusion of 18 patients.
  
  
  METHODS
  Creation of an endoscopic gastroenteric anastomosis by using the Cook Magnetic Anastomosis Device with transanastomotic deployment of a self-expandable stent.
  
  
  METHODS
  Primary endpoints were safety and success rate associated with the creation of an endoscopic gastrojejunostomy by using a magnetic anastomotic device with transanastomotic deployment of a self-expandable stent.
  
  
  RESULTS
  Because of a serious adverse event, the study was terminated prematurely. A success rate of 66.7% (12 of 18 patients) was achieved; 1 serious adverse event (stent perforation) occurred leading to the death of the patient. Three patients (25%) experienced an adverse device effect (stent migration).
  
  
  CONCLUSIONS
  Small sample size, lack of a control group.
  
  
  CONCLUSIONS
  Endoscopic creation of a gastroenteric anastomosis by magnetic compression is feasible and safe; however, the necessity of a stent led to serious morbidity and even mortality in this study. The current system can therefore not be recommended for clinical use.
authors.affiliation: Department of Gastroenterology and Hepatology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. j.e.vanhooft@amc.nl
authors.forename: Jeanin E
authors.initials: JE
authors.lastname: van Hooft
authors.forename: Frank P
authors.initials: FP
authors.lastname: Vleggaar
authors.forename: Olivier
authors.initials: O
authors.lastname: Le Moine
authors.forename: Alessandra
authors.initials: A
authors.lastname: Bizzotto
authors.forename: Rogier P
authors.initials: RP
authors.lastname: Voermans
authors.forename: Guido
authors.initials: G
authors.lastname: Costamagna
authors.forename: Jacques
authors.initials: J
authors.lastname: Devière
authors.forename: Peter D
authors.initials: PD
authors.lastname: Siersema
authors.forename: Paul
authors.initials: P
authors.lastname: Fockens
mesh_terms: D000368:Aged; D000714:Anastomosis, Surgical / Q000009:adverse effects / Q000295:instrumentation*; D001650:Bile Duct Neoplasms / Q000601:surgery*; D002404:Catheterization / Q000295:instrumentation; D018281:Cholangiocarcinoma / Q000601:surgery*; D015331:Cohort Studies; D020878:Device Removal; D004379:Duodenal Neoplasms / Q000601:surgery*; D057239:Early Termination of Clinical Trials; D005260:Female; D005471:Fluoroscopy; D015390:Gastric Bypass / Q000009:adverse effects / Q000295:instrumentation*; D017219:Gastric Outlet Obstruction / Q000601:surgery*; D006801:Humans; D008280:Magnetics / Q000295:instrumentation*; D008297:Male; D008875:Middle Aged; D010166:Palliative Care / Q000379:methods*; D010190:Pancreatic Neoplasms / Q000601:surgery*; D011446:Prospective Studies; D015607:Stents; D013274:Stomach Neoplasms / Q000601:surgery*