title: Non-adherence to the rule of 3 does not increase the risk of adverse events in esophageal dilation.
abstract: OBJECTIVE
  Although the rule of 3 is recommended to minimize the risk of perforation when esophageal dilation is performed using bougie dilators, there are no data to validate its use. Our aim was to investigate the association between the rule of 3 and adverse events (AEs) in esophageal dilation.
  
  
  METHODS
  A retrospective chart review in patients who underwent esophageal bougie or balloon dilation between December 1991 and February 2013 at a tertiary hospital was performed. Data collection included patient demographics, stricture and procedural characteristics, AEs, and follow-up. Univariate logistic regression models were used to assess the risk of AEs and perforations.
  
  
  RESULTS
  A total of 297 patients (median age, 63 years; 60% men) underwent 2216 esophageal bougie or balloon dilations. Major AEs occurred in 22 (1%) dilation sessions, including 11 (0.5%) perforations, 4 (0.2%) fistulas, 3 (0.1%) hospitalizations for pain management, 2 (0.09%) clinically significant hemorrhages, 1 (0.04%) fever, and 1 (0.04%) tracheoesophageal voice prosthesis leak. Mean duration of treatment was 43.2 months (standard deviation, 47.7 months). Most strictures were benign (n = 275; 93%) and complex in nature (n = 198; 67%). Non-adherence to the rule of 3 occurred in 190 (13%) dilations with bougie dilators. Non-adherence was not associated with a higher rate of major AEs (1/190, 0.5% vs 15/953, 1.6%; P = .18) and perforations (0/190, 0% vs 7/952, 0.7%; P = .18). Gender, complex strictures, location of the stricture, type of dilator, and additional interventions were also not associated with major AEs or perforations. However, malignant strictures were associated with an increased risk of major AEs (odds ratio, 3.5; 95% confidence interval, 1.1-12.0) and perforations (odds ratio, 8.3; 95% confidence interval, 2.2-31.9).
  
  
  CONCLUSIONS
  Non-adherence to the rule of 3 does not appear to increase the risk of AEs, particularly perforation, after esophageal dilation using bougie dilators. Caution is needed with the dilation of malignant strictures, as there is an increased risk of perforations and AEs. However, large prospective studies are needed to verify the results of this study.
authors: Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, the Netherlands; Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA; Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, the Netherlands.
authors: Karina V
authors: KV
authors: Grooteman
authors: Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
authors: Louis M
authors: LM
authors: Wong Kee Song
authors: Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, the Netherlands.
authors: Frank P
authors: FP
authors: Vleggaar
authors: Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, the Netherlands; Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, the Netherlands.
authors: Peter D
authors: PD
authors: Siersema
authors: Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA; Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, North Carolina, USA.
authors: Todd H
authors: TH
authors: Baron
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004106:Dilatation / Q000592:standards*; D004937:Esophageal Fistula / Q000453:epidemiology; D004939:Esophageal Perforation / Q000453:epidemiology; D004940:Esophageal Stenosis / Q000601:surgery*; D004945:Esophagoscopy / Q000592:standards*; D005260:Female; D005334:Fever / Q000453:epidemiology; D019983:Guideline Adherence / Q000706:statistics & numerical data*; D006760:Hospitalization; D006801:Humans; D007831:Larynx, Artificial; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D059408:Pain Management; D010149:Postoperative Pain / Q000453:epidemiology / Q000628:therapy; D011183:Postoperative Complications / Q000453:epidemiology*; D019106:Postoperative Hemorrhage / Q000453:epidemiology; D017410:Practice Guidelines as Topic; D012189:Retrospective Studies; D055815:Young Adult