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


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.


CONCLUSIONS
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.
Department of Gastroenterological Surgery, Kanazawa University Hospital, Kanazawa, Japan ; Digestive Disease Support Organization (DDSO), Kanazawa, Japan.
Sachio
S
Fushida
Department of Gastroenterological Surgery, Kanazawa University Hospital, Kanazawa, Japan ; Digestive Disease Support Organization (DDSO), Kanazawa, Japan.
Katsunobu
K
Oyama
Digestive Disease Support Organization (DDSO), Kanazawa, Japan.
Masahide
M
Kaji
Digestive Disease Support Organization (DDSO), Kanazawa, Japan.
Yasuo
Y
Hirono
Department of Gastroenterological Surgery, Kanazawa University Hospital, Kanazawa, Japan ; Digestive Disease Support Organization (DDSO), Kanazawa, Japan.
Jun
J
Kinoshita
Department of Gastroenterological Surgery, Kanazawa University Hospital, Kanazawa, Japan ; Digestive Disease Support Organization (DDSO), Kanazawa, Japan.
Tomoya
T
Tsukada
Digestive Disease Support Organization (DDSO), Kanazawa, Japan.
Hideaki
H
Nezuka
Digestive Disease Support Organization (DDSO), Kanazawa, Japan.
Tatsuo
T
Nakano
Digestive Disease Support Organization (DDSO), Kanazawa, Japan.
Masahiro
M
Noto
Digestive Disease Support Organization (DDSO), Kanazawa, Japan.
Koji
K
Nishijima
Digestive Disease Support Organization (DDSO), Kanazawa, Japan.
Takashi
T
Fujimura
Department of Gastroenterological Surgery, Kanazawa University Hospital, Kanazawa, Japan ; Digestive Disease Support Organization (DDSO), Kanazawa, Japan.
Tetsuo
T
Ohta
D000368:Aged; D001993:Bronchodilator Agents / Q000008:administration & dosage; D016903:Drug Monitoring / Q000379:methods; D005260:Female; D005743:Gastrectomy / Q000009:adverse effects / Q000379:methods / Q000534:rehabilitation; D006801:Humans; D008297:Male; D019990:Perioperative Care / Q000379:methods; D011183:Postoperative Complications / Q000517:prevention & control*; D029424:Pulmonary Disease, Chronic Obstructive / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy / Q000503:physiopathology; D012129:Respiratory Function Tests / Q000379:methods; D012720:Severity of Illness Index; D013274:Stomach Neoplasms / Q000150:complications / Q000601:surgery*; D000069447:Tiotropium Bromide / Q000008:administration & dosage*; D016896:Treatment Outcome
D001993:Bronchodilator Agents; D000069447:Tiotropium Bromide
COPD; gastric cancer; tiotropium