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Randomized Controlled Trial
. 2025 Jan;73(1):58-65.
doi: 10.1007/s11748-024-02083-1. Epub 2024 Sep 18.

Effect of Perioperative Inhaled Tiotropium for patients with chronic Obstructive Pulmonary disease in Esophageal cancer surgery (EPITOPE): an open-label, randomized, parallel-group pilot study

Akihiko Okamura  1 , Masayuki Watanabe  2 , Naoki Miyazaki  3 , Yoshiko Matsui  3 , Haruka Manoshiro  4 , Emi Furukawa  4 , Yasuhiro Tai  4 , Jun Kanamori  1 , Yu Imamura  1 , Satoru Kitazono  5
Affiliations
Randomized Controlled Trial

Effect of Perioperative Inhaled Tiotropium for patients with chronic Obstructive Pulmonary disease in Esophageal cancer surgery (EPITOPE): an open-label, randomized, parallel-group pilot study

Akihiko Okamura et al. Gen Thorac Cardiovasc Surg. 2025 Jan.

Abstract

Objective: Chronic obstructive pulmonary disease (COPD) is a risk factor for pneumonia following esophagectomy. This study aimed to investigate the efficacy of perioperative inhaled tiotropium in patients with COPD undergoing esophagectomy.

Methods: This open-label, randomized controlled trial randomly assigned 32 patients with COPD undergoing esophagectomy to conventional management or addition of tiotropium inhalation. The intervention group received tiotropium from two weeks before esophagectomy until the final evaluation one month after esophagectomy. The primary outcome was the incidence of pneumonia within 30 postoperative days. We also assessed the changes and the percentages from baseline in pulmonary function and walking distance of the incremental shuttle walking test to just before esophagectomy and final evaluation.

Results: Enrolled patients were randomly assigned to the control group (n = 18) and the intervention group (n = 14). Pneumonia was recorded in 4 (28.6%) and 5 (27.8%) patients in the intervention and control groups, respectively (risk difference: 0.8%, 95% confidence interval: - 30.6 to 32.2). The intervention group demonstrated a significant improvement in pulmonary function and walking distance preoperatively. Further, the pulmonary function test was significantly better preoperatively in the intervention group than in the control group. Postoperatively, pulmonary function deterioration was more significant in the control group than in the intervention group.

Conclusions: Preoperative tiotropium inhalation significantly improved pulmonary function and exercise tolerance in patients with COPD undergoing esophagectomy. The perioperative tiotropium did not reduce pneumonia after esophagectomy, but it may contribute to patient recovery by reducing postoperative pulmonary function deterioration.

Keywords: Chronic obstructive pulmonary disease; Esophagectomy; Pneumonia; Pulmonary function; Tiotropium.

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Conflict of interest statement

Declarations. Conflict of interest: The authors have no conflicts of interest to declare.

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