Quality of life following radiofrequency ablation of dysplastic Barrett’s esophagus

Background and study aims: The impact of the diagnosis and treatment of dysplastic Barrett’s esophagus on quality of life (QoL) is poorly understood. This study assessed the influence of dysplastic Barrett’s esophagus on QoL and evaluated whether endoscopic treatment of dysplastic Barrett’s esophagus with radiofrequency ablation (RFA) improves QoL.

Patients and methods: We analyzed changes in QoL in the AIM Dysplasia Trial, a multicenter study of patients with dysplastic Barrett’s esophagus who were randomly allocated to RFA therapy or a sham intervention. We developed a 10-item questionnaire to assess the influence of dysplastic Barrett’s esophagus on QoL. The questionnaire was completed by patients at baseline and 12 months.

Results: 127 patients were randomized to RFA (n = 84) or sham (n = 43). At baseline, most patients reported worry about esophageal cancer (71 % RFA, 85 % sham) and esophagectomy (61 % RFA, 68 % sham). Patients also reported depression, impaired QoL, worry, stress, and dissatisfaction with the condition of their esophagus. Of those randomized, 117 patients completed the study to the 12-month end point. Compared with the sham group, patients treated with RFA had significantly less worry about esophageal cancer (P = 0.003) and esophagectomy (P = 0.009). They also had significantly reduced depression (P = 0.02), general worry about the condition of their esophagus (P ≤ 0.001), impact on daily QoL (P = 0.009), stress (P = 0.03), dissatisfaction with the condition of their esophagus (P ≤ 0.001), and impact on work and family life (P = 0.02).

Conclusions: Inclusion in the treatment group of this randomized, sham-controlled trial of RFA was associated with improvement in disease-specific health-related quality of life. This improvement appears secondary to a perceived decrease in the risk of cancer.

References

• 1 Spechler S J. Clinical practice. Barrett’s esophagus.  N Engl J Med. 2002;  346 836-842
• 2 Sharma P, Falk G W, Weston A P. et al . Dysplasia and cancer in a large multicenter cohort of patients with Barrett’s esophagus.  Clin Gastroenterol Hepatol. 2006;  4 566-572
• 3 Overholt B F, Lightdale C J, Wang K K. et al . Photodynamic therapy with porfimer sodium for ablation of high-grade dysplasia in Barrett’s esophagus: international, partially blinded, randomized phase III trial.  Gastrointest Endosc. 2005;  62 488-498
• 4 Reid B J, Levine D S, Longton G. et al . Predictors of progression to cancer in Barrett’s esophagus: baseline histology and flow cytometry identify low- and high-risk patient subsets.  Am J Gastroenterol. 2000;  95 1669-1676
• 5 Rastogi A, Puli S, El-Serag H B. et al . Incidence of esophageal adenocarcinoma in patients with Barrett’s esophagus and high-grade dysplasia: a meta-analysis.  Gastrointest Endosc. 2008;  67 394-398
• 6 Eloubeidi M A, Mason A C, Desmond R A, El-Serag H B. Temporal trends (1973 – 11997) in survival of patients with esophageal adenocarcinoma in the United States: a glimmer of hope?.  Am J Gastroenterol. 2003;  98 1627-1633
• 7 Wenger N, Furberg , CD . Quality of life assessments in clinical trials. New York; Raven Press 1990
• 8 Crockett S D, Lippmann Q K, Dellon E S, Shaheen N J. Health-related quality of life in patients with Barrett’s esophagus: a systematic review.  Clin Gastroenterol Hepatol. 2009;  7 613-623
• 9 Shaheen N J, Dulai G S, Ascher B. et al . Effect of a new diagnosis of Barrett’s esophagus on insurance status.  Am J Gastroenterol. 2005;  100 577-580
• 10 Birkmeyer J D, Stukel T A, Siewers A E. et al . Surgeon volume and operative mortality in the United States.  N Engl J Med. 2003;  349 2117-2127
• 11 Moraca R J, Low D E. Outcomes and health-related quality of life after esophagectomy for high-grade dysplasia and intramucosal cancer.  Arch Surg. 2006;  141 545-549; discussion 549 – 551
• 12 Chang L C, Oelschlager B K, Quiroga E. et al . Long-term outcome of esophagectomy for high-grade dysplasia or cancer found during surveillance for Barrett’s esophagus.  J Gastrointest Surg. 2006;  10 341-346
• 13 Headrick J R, Nichols 3rd F C, Miller D L. et al . High-grade esophageal dysplasia: long-term survival and quality of life after esophagectomy.  Ann Thorac Surg. 2002;  73 1697-1702; discussion 1702 – 1693
• 14 Shaheen N J, Sharma P, Overholt B F. et al . Radiofrequency ablation in Barrett’s esophagus with dysplasia.  N Engl J Med. 2009;  360 2277-2288
• 15 Cherepanov D, Palta M, Fryback D G, Robert S A. Gender differences in health-related quality-of-life are partly explained by sociodemographic and socioeconomic variation between adult men and women in the US: evidence from four US nationally representative data sets.  Qual Life Res. 2010;  [Epub ahead of print]
• 16 Kaplan G A, Camacho T. Perceived health and mortality: a nine-year follow-up of the human population laboratory cohort.  Am J Epidemiol. 1983;  117 292-304
• 17 Schembre D, Arai A, Levy S. et al . Quality of life after esophagectomy and endoscopic therapy for Barrett’s esophagus with dysplasia.  Dis Esophagus. 2010;  23 458-464
• 18 Patrick D L, Deyo R A. Generic and disease-specific measures in assessing health status and quality of life.  Med Care. 1989;  27 S217-S232
• 19 McSweeny A J, Creer T L. Health-related quality-of-life assessment in medical care.  Dis Mon. 1995;  41 1-71

1 See Appendix 1.

2 All institutions and locations are in the US.