Karina V Grooteman1, Louis M Wong Kee Song2, Frank P Vleggaar3, Peter D Siersema4, Todd H Baron5. 1. 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. 2. Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA. 3. Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, the Netherlands. 4. Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, the Netherlands; Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, the Netherlands. 5. Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA; Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, North Carolina, USA.
Abstract
BACKGROUND AND AIMS: 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.
BACKGROUND AND AIMS: 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: Sarmed S Sami; Hasan N Haboubi; Yeng Ang; Philip Boger; Pradeep Bhandari; John de Caestecker; Helen Griffiths; Rehan Haidry; Hans-Ulrich Laasch; Praful Patel; Stuart Paterson; Krish Ragunath; Peter Watson; Peter D Siersema; Stephen E Attwood Journal: Gut Date: 2018-02-24 Impact factor: 23.059
Authors: Emo E van Halsema; Chantal A 't Hoen; Patricia S de Koning; Wilda D Rosmolen; Jeanin E van Hooft; Jacques J Bergman Journal: Surg Endosc Date: 2018-01-18 Impact factor: 4.584
Authors: W F Kappelle; J E van Hooft; M C W Spaander; F P Vleggaar; M J Bruno; F Maluf-Filho; A Bogte; E van Halsema; P D Siersema Journal: Endosc Int Open Date: 2019-01-18