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A randomized multicenter Phase II study of perioperative tiotropium intervention in gastric cancer patients with chronic obstructive pulmonary disease.

Fushida S, Oyama K, Kaji M, Hirono Y, Kinoshita J, Tsukada T, Nezuka H, Nakano T, Noto M, Nishijima K, Fujimura T, Ohta T - Int J Chron Obstruct Pulmon Dis (2015)

Bottom Line: Postoperative complications, forced expiratory volume in 1 second, forced vital capacity, and the ratio of forced expiratory volume in second to forced vital capacity (%) were compared between the two groups.There were no significant differences between the two groups in terms of age, body mass index, smoking, gastrectomy incision, operation time, and bleeding volume (all P>0.05).A subgroup analysis of gastric cancer patients with moderate COPD showed that perioperative tiotropium intervention significantly decreased the rate of postoperative complications compared with the control group (P=0.046).

View Article: PubMed Central - PubMed

Affiliation: Department of Gastroenterological Surgery, Kanazawa University Hospital, Kanazawa, Japan ; Digestive Disease Support Organization (DDSO), Kanazawa, Japan.

ABSTRACT

Background: Tiotropium, a long-acting inhaled anticholinergic drug, has been widely used in the treatment of chronic obstructive pulmonary disease (COPD). However, the issue of whether perioperative tiotropium improves postoperative outcomes for gastric cancer patients with COPD remains unclear. Thus, the aim of this study was to determine the efficacy of perioperative tiotropium intervention for gastric cancer patients with COPD.

Patients and methods: Eighty-four gastric cancer patients with mild-to-moderate COPD were randomly assigned to receive perioperative pulmonary rehabilitation alone (control group) or pulmonary rehabilitation with 18 µg of tiotropium once daily (tiotropium group). The patients in the tiotropium group received tiotropium for more than 1 week before surgery and for 2 weeks after surgery. Spirometry was performed prior to group assignment and at 2 weeks after surgery. Postoperative complications, forced expiratory volume in 1 second, forced vital capacity, and the ratio of forced expiratory volume in second to forced vital capacity (%) were compared between the two groups.

Results: There were no significant differences between the two groups in terms of age, body mass index, smoking, gastrectomy incision, operation time, and bleeding volume (all P>0.05). Postoperative complications and pulmonary functions did not differ significantly between the control and tiotropium groups. A subgroup analysis of gastric cancer patients with moderate COPD showed that perioperative tiotropium intervention significantly decreased the rate of postoperative complications compared with the control group (P=0.046). However, even after gastrectomy, many patients with mild COPD in both the control and tiotropium groups showed improved pulmonary function.

Conclusion: Although perioperative tiotropium intervention had no significant effects in gastric cancer patients with mild COPD, it may be beneficial in those with moderate COPD. Therefore, the next prospective study should further evaluate perioperative tiotropium intervention for gastric cancer patients with moderate-to-severe COPD.

No MeSH data available.


Related in: MedlinePlus

Flow diagram of the 84 enrolled patients.Abbreviations: Pt, patient; ESD, endoscopic submucosal dissection; Reope, performed reoperation; Spiro, spirometry.
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f1-copd-10-2177: Flow diagram of the 84 enrolled patients.Abbreviations: Pt, patient; ESD, endoscopic submucosal dissection; Reope, performed reoperation; Spiro, spirometry.

Mentions: Between December 2010 and May 2013, 84 patients were enrolled in this randomized study carried out in 15 hospitals in Japan. Of these, 42 patients were assigned to the control arm and 42 to the tiotropium arm. A flow diagram of the 84 enrolled patients is shown in Figure 1. One patient refused to undergo surgical treatment and another patient completed treatment with endoscopic submucosal dissection. The demographic characteristics of the remaining 82 patients are presented in Table 1. There were no significant differences in the characteristics of the two groups. After surgical treatment, spirometry could not be performed in two patients because of reoperation and unforced errors. Finally, 80 patients (38 patients in the control arm and 42 patients in the tiotropium arm) were evaluated.


A randomized multicenter Phase II study of perioperative tiotropium intervention in gastric cancer patients with chronic obstructive pulmonary disease.

Fushida S, Oyama K, Kaji M, Hirono Y, Kinoshita J, Tsukada T, Nezuka H, Nakano T, Noto M, Nishijima K, Fujimura T, Ohta T - Int J Chron Obstruct Pulmon Dis (2015)

Flow diagram of the 84 enrolled patients.Abbreviations: Pt, patient; ESD, endoscopic submucosal dissection; Reope, performed reoperation; Spiro, spirometry.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4608619&req=5

f1-copd-10-2177: Flow diagram of the 84 enrolled patients.Abbreviations: Pt, patient; ESD, endoscopic submucosal dissection; Reope, performed reoperation; Spiro, spirometry.
Mentions: Between December 2010 and May 2013, 84 patients were enrolled in this randomized study carried out in 15 hospitals in Japan. Of these, 42 patients were assigned to the control arm and 42 to the tiotropium arm. A flow diagram of the 84 enrolled patients is shown in Figure 1. One patient refused to undergo surgical treatment and another patient completed treatment with endoscopic submucosal dissection. The demographic characteristics of the remaining 82 patients are presented in Table 1. There were no significant differences in the characteristics of the two groups. After surgical treatment, spirometry could not be performed in two patients because of reoperation and unforced errors. Finally, 80 patients (38 patients in the control arm and 42 patients in the tiotropium arm) were evaluated.

Bottom Line: Postoperative complications, forced expiratory volume in 1 second, forced vital capacity, and the ratio of forced expiratory volume in second to forced vital capacity (%) were compared between the two groups.There were no significant differences between the two groups in terms of age, body mass index, smoking, gastrectomy incision, operation time, and bleeding volume (all P>0.05).A subgroup analysis of gastric cancer patients with moderate COPD showed that perioperative tiotropium intervention significantly decreased the rate of postoperative complications compared with the control group (P=0.046).

View Article: PubMed Central - PubMed

Affiliation: Department of Gastroenterological Surgery, Kanazawa University Hospital, Kanazawa, Japan ; Digestive Disease Support Organization (DDSO), Kanazawa, Japan.

ABSTRACT

Background: Tiotropium, a long-acting inhaled anticholinergic drug, has been widely used in the treatment of chronic obstructive pulmonary disease (COPD). However, the issue of whether perioperative tiotropium improves postoperative outcomes for gastric cancer patients with COPD remains unclear. Thus, the aim of this study was to determine the efficacy of perioperative tiotropium intervention for gastric cancer patients with COPD.

Patients and methods: Eighty-four gastric cancer patients with mild-to-moderate COPD were randomly assigned to receive perioperative pulmonary rehabilitation alone (control group) or pulmonary rehabilitation with 18 µg of tiotropium once daily (tiotropium group). The patients in the tiotropium group received tiotropium for more than 1 week before surgery and for 2 weeks after surgery. Spirometry was performed prior to group assignment and at 2 weeks after surgery. Postoperative complications, forced expiratory volume in 1 second, forced vital capacity, and the ratio of forced expiratory volume in second to forced vital capacity (%) were compared between the two groups.

Results: There were no significant differences between the two groups in terms of age, body mass index, smoking, gastrectomy incision, operation time, and bleeding volume (all P>0.05). Postoperative complications and pulmonary functions did not differ significantly between the control and tiotropium groups. A subgroup analysis of gastric cancer patients with moderate COPD showed that perioperative tiotropium intervention significantly decreased the rate of postoperative complications compared with the control group (P=0.046). However, even after gastrectomy, many patients with mild COPD in both the control and tiotropium groups showed improved pulmonary function.

Conclusion: Although perioperative tiotropium intervention had no significant effects in gastric cancer patients with mild COPD, it may be beneficial in those with moderate COPD. Therefore, the next prospective study should further evaluate perioperative tiotropium intervention for gastric cancer patients with moderate-to-severe COPD.

No MeSH data available.


Related in: MedlinePlus