Kenji Suzuki1, Hisashi Saji2, Keiju Aokage3, Shun-Ichi Watanabe4, Morihito Okada5, Junki Mizusawa6, Ryu Nakajima7, Masahiro Tsuboi3, Shinichiro Nakamura8, Kenichi Nakamura6, Tetsuya Mitsudomi9, Hisao Asamura10. 1. Department of General Thoracic Surgery, Juntendo University School of Medicine, Tokyo, Japan. Electronic address: kjsuzuki@juntendo.ac.jp. 2. Department of General Thoracic Surgery, St Marianna University School of Medicine, Kanagawa, Japan. 3. Division of Thoracic Surgery, National Cancer Center Hospital East, Chiba, Japan. 4. Division of Thoracic Surgery, National Cancer Center Hospital, Tokyo, Japan. 5. Department of Thoracic Surgery, Hiroshima University Hospital, Hiroshima, Japan. 6. Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan. 7. Department of Thoracic Surgery, Osaka City General Medical Center, Osaka, Japan. 8. West Japan Oncology Group Data Center, Osaka, Japan. 9. Department of Surgery, Kindai University Faculty of Medicine, Osaka, Japan. 10. Division of Thoracic Surgery, Keio University School of Medicine, Tokyo, Japan.
Abstract
BACKGROUND: No definitive comparisons of surgical morbidity between segmentectomy and lobectomy for non-small cell lung cancer have been reported. METHODS: We conducted a randomized controlled trial to confirm the noninferiority of segmentectomy to lobectomy in regard to prognosis (trial No. JCOG0802/WJOG4607L). Patients with invasive peripheral non-small cell lung cancer tumor of a diameter ≤2 cm were randomized to undergo either lobectomy or segmentectomy. The primary end point was overall survival. Here, we have focused on morbidity and mortality. Predictors of surgical morbidity were evaluated by the mode of surgery. Segmentectomy was categorized into simple and complex. Simple segmentectomy was defined as segmental resection of the right or left segment 6, left superior, or lingular segment. Complex segmentectomy was resection of the other segment. This trial is registered with the University Hospital Medical Information Network--Clinical Trial Registry (UMIN000002317). RESULTS:Between August 10, 2009, and October 21, 2014, 1106 patients (lobectomy n = 554 and segmentectomy n = 552) were enrolled. No mortality was noted. Complications (grade ≥ 2) occurred in 26.2% and 27.4% in the lobectomy and segmentectomy arms (P = .68), respectively. Fistula/pulmonary-lung (air leak) was detected in 21 (3.8%) and 36 (6.5%) patients in the lobectomy and segmentectomy arms (P = .04), respectively. Multivariable analysis revealed that predictors of pulmonary complications, including air leak and empyema (grade ≥ 2) were complex segmentectomy (vs lobectomy) (odds ratio, 2.07; 95% confidence interval, 1.11-3.88; P = .023), and > 20 pack-years of smoking (odds ratio, 2.61; 95% confidence interval, 1.14-5.97; P = .023). CONCLUSIONS: There was no difference in almost any postoperative measure of intraoperative and postoperative complication in segmentectomy and lobectomy patients, except more air leakage was observed in the segmentectomy arm. Segmentectomy will be a standard treatment if the superior pulmonary function and noninferiority in overall survival are confirmed.
RCT Entities:
BACKGROUND: No definitive comparisons of surgical morbidity between segmentectomy and lobectomy for non-small cell lung cancer have been reported. METHODS: We conducted a randomized controlled trial to confirm the noninferiority of segmentectomy to lobectomy in regard to prognosis (trial No. JCOG0802/WJOG4607L). Patients with invasive peripheral non-small cell lung cancer tumor of a diameter ≤2 cm were randomized to undergo either lobectomy or segmentectomy. The primary end point was overall survival. Here, we have focused on morbidity and mortality. Predictors of surgical morbidity were evaluated by the mode of surgery. Segmentectomy was categorized into simple and complex. Simple segmentectomy was defined as segmental resection of the right or left segment 6, left superior, or lingular segment. Complex segmentectomy was resection of the other segment. This trial is registered with the University Hospital Medical Information Network--Clinical Trial Registry (UMIN000002317). RESULTS: Between August 10, 2009, and October 21, 2014, 1106 patients (lobectomy n = 554 and segmentectomy n = 552) were enrolled. No mortality was noted. Complications (grade ≥ 2) occurred in 26.2% and 27.4% in the lobectomy and segmentectomy arms (P = .68), respectively. Fistula/pulmonary-lung (air leak) was detected in 21 (3.8%) and 36 (6.5%) patients in the lobectomy and segmentectomy arms (P = .04), respectively. Multivariable analysis revealed that predictors of pulmonary complications, including air leak and empyema (grade ≥ 2) were complex segmentectomy (vs lobectomy) (odds ratio, 2.07; 95% confidence interval, 1.11-3.88; P = .023), and > 20 pack-years of smoking (odds ratio, 2.61; 95% confidence interval, 1.14-5.97; P = .023). CONCLUSIONS: There was no difference in almost any postoperative measure of intraoperative and postoperative complication in segmentectomy and lobectomy patients, except more air leakage was observed in the segmentectomy arm. Segmentectomy will be a standard treatment if the superior pulmonary function and noninferiority in overall survival are confirmed.
Authors: Vignesh Raman; Oliver K Jawitz; Chi-Fu Jeffrey Yang; Soraya L Voigt; Thomas A D'Amico; David H Harpole; Betty C Tong Journal: J Thorac Cardiovasc Surg Date: 2020-03-22 Impact factor: 5.209
Authors: Vignesh Raman; Oliver K Jawitz; Soraya L Voigt; Kristen E Rhodin; Thomas A D'Amico; David H Harpole; Chi-Fu Jeffrey Yang; Betty C Tong Journal: Chest Date: 2020-07-08 Impact factor: 9.410