TY - JOUR
T1 - A multicenter randomized controlled trial of surgery alone or surgery with atrial natriuretic peptide in lung cancer surgery
T2 - Study protocol for a randomized controlled trial
AU - on behalf of the Japan Human Atrial Natriuretic Peptide for Lung Cancer Surgery (JANP Study) Group
AU - Nojiri, Takashi
AU - Yamamoto, Haruko
AU - Hamasaki, Toshimitsu
AU - Onda, Kaori
AU - Ohshima, Kikuko
AU - Shintani, Yasushi
AU - Okumura, Meinoshin
AU - Kangawa, Kenji
AU - Nakajima, Jun
AU - Tsuboi, Masahiro
AU - Hida, Yasuhiro
AU - Maniwa, Yoshimasa
AU - Oizumi, Hiroyuki
AU - Higashiyama, Masahiko
AU - Takeuchi, Yukiyasu
AU - Kadota, Yoshihisa
AU - Shiono, Satoshi
N1 - Publisher Copyright:
© 2017 The Author(s).
PY - 2017/4/20
Y1 - 2017/4/20
N2 - Background: Postoperative cancer recurrence is a major problem following curative surgery. In a previous retrospective study of lung cancer surgery, we reported that administration of atrial natriuretic peptide (ANP) during the perioperative period reduced postoperative recurrence. We demonstrated that ANP inhibited the adhesion of cancer cells to vascular endothelium as a vasoprotective action. The objective of this study is to evaluate the effects of ANP on the incidence of postoperative cancer recurrence in lung cancer surgery. Methods/design: The present study is a multicenter, randomized trial with two parallel groups of patients with lung cancer comparing surgery alone and surgery with ANP administration for 3 days during the perioperative period. A total of 500 patients will be enrolled from 10 Japanese institutions. The primary endpoint is 2-year relapse-free survival (RFS). The secondary endpoints are 2-year cancer-specific RFS, 5-year RFS, overall survival, the incidence of postoperative complications, and the completion rate of ANP treatment. Discussion: The principal question addressed in this trial is whether ANP with its vasoprotective action can reduce cancer recurrence following lung cancer surgery. Trial registration: UMIN Clinical Trials Registry identifier: UMIN000018480. Registered on 31 July 2015.
AB - Background: Postoperative cancer recurrence is a major problem following curative surgery. In a previous retrospective study of lung cancer surgery, we reported that administration of atrial natriuretic peptide (ANP) during the perioperative period reduced postoperative recurrence. We demonstrated that ANP inhibited the adhesion of cancer cells to vascular endothelium as a vasoprotective action. The objective of this study is to evaluate the effects of ANP on the incidence of postoperative cancer recurrence in lung cancer surgery. Methods/design: The present study is a multicenter, randomized trial with two parallel groups of patients with lung cancer comparing surgery alone and surgery with ANP administration for 3 days during the perioperative period. A total of 500 patients will be enrolled from 10 Japanese institutions. The primary endpoint is 2-year relapse-free survival (RFS). The secondary endpoints are 2-year cancer-specific RFS, 5-year RFS, overall survival, the incidence of postoperative complications, and the completion rate of ANP treatment. Discussion: The principal question addressed in this trial is whether ANP with its vasoprotective action can reduce cancer recurrence following lung cancer surgery. Trial registration: UMIN Clinical Trials Registry identifier: UMIN000018480. Registered on 31 July 2015.
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U2 - 10.1186/s13063-017-1928-1
DO - 10.1186/s13063-017-1928-1
M3 - Article
C2 - 28427456
AN - SCOPUS:85018530058
SN - 1745-6215
VL - 18
JO - Trials
JF - Trials
IS - 1
M1 - 183
ER -