ヤマグチ　シゲキ   YAMAGUCHI SHIGEKI   山口　茂樹    所属   医学部 医学科（東京女子医科大学病院）    職種   教授・基幹分野長
論文種別	原著
言語種別	英語
査読の有無	査読なし
表題	Japanese multicenter prospective study investigating laparoscopic surgery for locally advanced rectal cancer with evaluation of CRM and TME quality (PRODUCT trial).
掲載誌名	正式名：Annals of gastroenterological surgery 略　 称：Ann Gastroenterol Surg ISSNコード：24750328/24750328
掲載区分	国外
巻・号・頁	6(6),pp.767-777
著者・共著者	Takemasa Ichiro, Hamabe Atsushi, Ito Masaaki, Matoba Shuichiro, Watanabe Jun, Hasegawa Suguru, Kotake Masanori, Inomata Masafumi, Ueda Kazuki, Uehara Kay, Sakamoto Kazuhiro, Ikeda Masataka, Hanai Tsunekazu, Konishi Tsuyoshi, Yamaguchi Shigeki, Nakano Daisuke, Yamagishi Shigeru, Okita Kenji, Ochiai Atsushi, Sakai Yoshiharu, Watanabe Masahiko,
発行年月	2022/11
概要	AIM:In Japan, we have not been able to validate the results of laparoscopic surgery for locally advanced rectal cancer using the universal index "circumferential resection margin (CRM)." Previously, we established a semi-opened circular specimen processing method and validated its feasibility. In the PRODUCT trial, we aimed to assess CRM in patients with locally advanced rectal cancer who underwent laparoscopic rectal resection.METHODS:This was a multicenter, prospective, observational study. Eligible patients had histologically confirmed rectal adenocarcinoma located at or below 12 cm above the anal verge with clinical stage II or III and were scheduled for laparoscopic or robotic surgery. The primary endpoint was pathological CRM. CRM ≤1 mm was defined as positive.RESULTS:A total of 303 patients operated on between August 2018 and January 2020 were included in the primary analysis. The number of patients with clinical stage II and III was 139 and 164, respectively. Upfront surgery was performed for 213 patients and neoadjuvant therapy for 90 patients. The median CRM was 4.0 mm (IQR, 2.1-8.0 mm), and CRM was positive in 26 cases (8.6%). Univariate and multivariate analyses demonstrated that a predicted CRM from the mesorectal fascia of ≤1 mm on MRI was the significant factor for positive CRM (P = .0012 and P = .0045, respectively).CONCLUSION:This study showed the quality of laparoscopic rectal resection based on the CRM in Japan. Preoperative MRI is recommended for locally advanced rectal cancer to prevent CRM positivity.
DOI	10.1002/ags3.12592
PMID	36338586