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. 2022 Jul 3;6(6):767-777.
doi: 10.1002/ags3.12592. eCollection 2022 Nov.

Japanese multicenter prospective study investigating laparoscopic surgery for locally advanced rectal cancer with evaluation of CRM and TME quality (PRODUCT trial)

Ichiro Takemasa  1 , Atsushi Hamabe  1 , Masaaki Ito  2 , Shuichiro Matoba  3 , Jun Watanabe  4 , Suguru Hasegawa  5 , Masanori Kotake  6 , Masafumi Inomata  7 , Kazuki Ueda  8 , Kay Uehara  9 , Kazuhiro Sakamoto  10 , Masataka Ikeda  11 , Tsunekazu Hanai  12 , Tsuyoshi Konishi  13 , Shigeki Yamaguchi  14 , Daisuke Nakano  15 , Shigeru Yamagishi  16 , Kenji Okita  1 , Atsushi Ochiai  17 , Yoshiharu Sakai  18 , Masahiko Watanabe  19 ; Japan Society of Laparoscopic Colorectal Surgery
Affiliations

Japanese multicenter prospective study investigating laparoscopic surgery for locally advanced rectal cancer with evaluation of CRM and TME quality (PRODUCT trial)

Ichiro Takemasa et al. Ann Gastroenterol Surg. .

Abstract

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.

Keywords: laparoscopy; magnetic resonance imaging; margins of excision; rectal neoplasms; total mesorectal excision.

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Figures

FIGURE 1
FIGURE 1
Flow of patient inclusion in the PRODUCT trial
See this image and copyright information in PMC

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