title: Endoscopic gastrostomy replacement tubes: long-term randomized trial with five silicone commercial models.
abstract: METHODS
  No analysis of the long-term performance of percutaneous endoscopic gastrostomy (PEG) replacement tubes was identified. A randomized partially blinded trial was designed hypothesizing that clinically relevant limitations of the tubes would be identified.
  
  
  METHODS
  Patients (N = 100, age 58.3 ± 20.7 years, 42.0% males, time with PEG 27.0 ± 22.5 months) were randomized in five parallel intervention groups, each with a tested device (Silmag(®), Bard(®), Freka(®), Kangaroo(®) and Wilson Cook(®)). Eligibility criteria included age 18-90 years, males and females, on home enteral nutrition, and the setting was a large academic hospital. Patients were allocated according to a random numbers list, and independent professionals were responsible for data collection. Primary outcome was tube longevity, calculated by Kaplan-Meier curves and Cox regression analysis. A sample of 18 was calculated based on a 10% effect size and 80% power.
  
  
  RESULTS
  Twenty patients were randomized in each group and all were analyzed. There was no morbidity and mortality, however tube dysfunction was common with all models. Fastener sliding occurred in 57.0% and balloon rupture in 32.0%, along with other mishaps. Best tube longevity corresponded to the Wilson Cook model (158.0 ± 10.0 days, P < 0.05), mostly on account of diminished balloon ruptures.
  
  
  CONCLUSIONS
  PEG replacement was safe however relatively frequent and affecting longevity, therefore longer-lasting tubes are needed. Specific attention should be given to cap, feeding line, external clamp, tube fastener; tube length, and notably balloon performance, which may be disappointing. Trial NCT01698827, CNPq Investigator Grant 302915/2011-7.
authors.affiliation: Endoscopy Service, Hospital das Clinicas, Sao Paulo, Brazil. Electronic address: Emanuelevillela@yahoo.com.br.
authors.forename: Emanuele L
authors.initials: EL
authors.lastname: Villela
authors.affiliation: Endoscopy Service, Hospital das Clinicas, Sao Paulo, Brazil. Electronic address: paulosakai@terra.com.br.
authors.forename: Paulo
authors.initials: P
authors.lastname: Sakai
authors.affiliation: Endoscopy Service, Hospital das Clinicas, Sao Paulo, Brazil. Electronic address: mairaralmeida@hotmail.com.
authors.forename: Maira R
authors.initials: MR
authors.lastname: Almeida
authors.affiliation: Endoscopy Service, Hospital das Clinicas, Sao Paulo, Brazil. Electronic address: eduardoghdemoura@gmail.com.
authors.forename: Eduardo G H
authors.initials: EG
authors.lastname: Moura
authors.affiliation: Department of Gastroenterology, Hospital das Clinicas, Sao Paulo, Brazil. Electronic address: j.faintuch@hc.fm.usp.br.
authors.forename: Joel
authors.initials: J
authors.lastname: Faintuch
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018592:Cross-Over Studies; D004724:Endoscopy / Q000295:instrumentation*; D004750:Enteral Nutrition / Q000295:instrumentation*; D005260:Female; D005774:Gastrostomy; D006801:Humans; D007441:Intubation, Gastrointestinal; D008297:Male; D008875:Middle Aged; D012828:Silicones / Q000737:chemistry*; D055815:Young Adult
chemical_list: D012828:Silicones
keywords: Balloon rupture; Complications; Kaplan–Meier curves; Longevity; Percutaneous endoscopic gastrostomy; Replacement tubes