YAMAGUCHI SHIGEKI
   Department   School of Medicine(Tokyo Women's Medical University Hospital), School of Medicine
   Position   Professor and Division head
Article types Original article
Language English
Peer review Non peer reviewed
Title Japanese multicenter prospective study investigating laparoscopic surgery for locally advanced rectal cancer with evaluation of CRM and TME quality (PRODUCT trial).
Journal Formal name:Annals of gastroenterological surgery
Abbreviation:Ann Gastroenterol Surg
ISSN code:24750328/24750328
Domestic / ForeginForegin
Volume, Issue, Page 6(6),pp.767-777
Author and coauthor 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,
Publication date 2022/11
Summary 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