Feasibility of robotic-assisted surgery in advanced rectal cancer: a multicentre prospective phase II study (VITRUVIANO trial)

被引：9

作者：

Hamabe, Atsushi ^{[1
,2
]}

Takemasa, Ichiro ^{[2
]}

Kotake, Masanori ^{[3
]}

Nakano, Daisuke ^{[4
]}

Hasegawa, Suguru ^{[5
]}

Shiomi, Akio ^{[6
]}

Numata, Masakatsu ^{[7
]}

Sakamoto, Kazuhiro ^{[8
]}

Kimura, Kei ^{[9
]}

Hanai, Tsunekazu ^{[10
]}

Naitoh, Takeshi ^{[11
]}

Fukunaga, Yosuke ^{[12
]}

Kinugasa, Yusuke ^{[13
]}

Watanabe, Jun ^{[14
]}

Kawamura, Junichiro ^{[15
]}

Ozawa, Mayumi ^{[16
]}

Okabayashi, Koji ^{[17
]}

Matoba, Shuichiro ^{[18
]}

Takano, Yoshinao ^{[19
]}

Uemura, Mamoru ^{[1
]}

Kanemitsu, Yukihide ^{[20
]}

Sakai, Yoshiharu ^{[21
]}

Watanabe, Masahiko ^{[22
]}

机构：

[1] Osaka Univ, Grad Sch Med, Dept Gastroenterol Surg, 2-2-E2 Yamadaoka, Suita, Osaka 5650871, Japan

[2] Sapporo Med Univ, Dept Surg Surg Oncol & Sci, S1 W16,Chuo Ku, Sapporo, Hokkaido 0608543, Japan

[3] Koseiren Takaoka Hosp, Dept Surg, Takaoka, Toyama, Japan

[4] Komagome Hosp, Tokyo Metropolitan Canc & Infect Dis Ctr, Dept Surg, Tokyo, Japan

[5] Fukuoka Univ, Fac Med, Dept Gastroenterol Surg, Fukuoka, Japan

[6] Shizuoka Canc Ctr Hosp, Div Colon & Rectal Surg, Nagaizumi, Shizuoka, Japan

[7] Yokohama City Univ, Dept Surg, Yokohama, Kanagawa, Japan

[8] Juntendo Univ, Fac Med, Dept Coloproctol Surg, Tokyo, Japan

[9] Hyogo Med Univ, Dept Gastroenterol Surg, Div Lower GI, Nishinomiya, Hyogo, Japan

[10] Fujita Hlth Univ, Sch Med, Dept Surg, Toyoake, Aichi, Japan

[11] Kitasato Univ, Sch Med, Dept Lower Gastrointestinal Surg, Sagamihara, Kanagawa, Japan

[12] Japanese Fdn Canc Res, Canc Inst Hosp, Gastroenterol Ctr, Dept Gastroenterol Surg, Tokyo, Japan

[13] Tokyo Med & Dent Univ, Grad Sch Med, Dept Gastrointestinal Surg, Tokyo, Japan

[14] Yokohama City Univ, Gastroenterol Ctr, Med Ctr, Dept Surg, Yokohama, Kanagawa, Japan

[15] Kindai Univ, Fac Med, Dept Surg, Osakasayama, Japan

[16] Yokohama City Univ, Grad Sch Med, Dept Gastroenterol Surg, Yokohama, Kanagawa, Japan

[17] Keio Univ, Sch Med, Dept Surg, Tokyo, Japan

[18] Toranomon Gen Hosp, Dept Gastroenterol Surg, Tokyo, Japan

[19] Southern TOHOKU Gen Hosp, Southern TOHOKU Res Inst Neurosci, Dept Surg Oncol, Koriyama, Fukushima, Japan

[20] Natl Canc Ctr, Dept Colorectal Surg, Tokyo, Japan

[21] Osaka Red Cross Hosp, Dept Surg, Osaka, Japan

[22] Kitasato Univ, Kitasato Inst Hosp, Dept Surg, Tokyo, Japan

来源：

BJS OPEN | 2024年 / 8卷 / 03期

关键词：

SHORT-TERM-OUTCOMES; LAPAROSCOPIC SURGERY; CIRCUMFERENTIAL MARGIN; PATHOLOGICAL OUTCOMES; MESORECTAL EXCISION; LOCAL RECURRENCE; LEARNING-CURVE; OPEN RESECTION; STAGE-II;

D O I：

10.1093/bjsopen/zrae048

中图分类号：

R61 [外科手术学];

学科分类号：

摘要：

Background The potential benefits of robotic-assisted compared with laparoscopic surgery for locally advanced cancer have not been sufficiently proven by prospective studies. One factor is speculated to be the lack of strict surgeon criteria. The aim of this study was to assess outcomes for robotic surgery in patients with locally advanced rectal cancer with strict surgeon experience criteria.Methods A criterion was set requiring surgeons to have performed more than 40 robotically assisted operations for rectal cancer. Between March 2020 and May 2022, patients with rectal cancer (distance from the anal verge of 12 cm or less, cT2-T4a, cN0-N3, cM0, or cT1-T4a, cN1-N3, cM0) were registered. The primary endpoint was the rate positive circumferential resection margin (CRM) from the pathological specimen. Secondary endpoints were surgical outcomes, pathological results, postoperative complications, and longterm outcomes.Results Of the 321 registered patients, 303 were analysed, excluding 18 that were ineligible. At diagnosis: stage I (n = 68), stage II (n = 84) and stage III (n = 151). Neoadjuvant therapy was used in 56 patients. There were no conversions to open surgery. The median console time to rectal resection was 170 min, and the median blood loss was 5 ml. Fourteen patients had a positive CRM (4.6%). Grade III-IV postoperative complications were observed in 13 patients (4.3%).Conclusion Robotic-assisted surgery is feasible for locally advanced rectal cancer when strict surgeon criteria are used. We are the first in Japan to conduct the multicentre prospective VITRUVIANO trial to evaluate the oncological utility of robotic surgery for advanced rectal cancer. In this article, we report the results of this analysis. In this trial, by setting stricter surgical qualifications compared with those of past clinical trials, we were able to control the quality of the surgery and, as a result, demonstrate favourable outcomes.

引用

页数：7

共 31 条

[1] ROLE OF CIRCUMFERENTIAL MARGIN INVOLVEMENT IN THE LOCAL RECURRENCE OF RECTAL-CANCER [J].

ADAM, IJ ;

MOHAMDEE, MO ;

MARTIN, IG ;

SCOTT, N ;

FINAN, PJ ;

JOHNSTON, D ;

DIXON, MF ;

QUIRKE, P .

LANCET, 1994, 344 (8924) :707-711

[2] Clinical impact of Endoscopic Surgical Skill Qualification System (ESSQS) by Japan Society for Endoscopic Surgery (JS']JSES) for laparoscopic distal gastrectomy and low anterior resection based on the National Clinical Database (NCD) registry [J].

Akagi, Tomonori ;

Endo, Hideki ;

Inomata, Masafumi ;

Yamamoto, Hiroyuki ;

Mori, Toshiyuki ;

Kojima, Kazuyuki ;

Kuroyanagi, Hiroya ;

Sakai, Yoshiharu ;

Nakajima, Kentaro ;

Shiroshita, Hidefumi ;

Etoh, Tsuyoshi ;

Saida, Yoshihisa ;

Yamamoto, Seiichiro ;

Hasegawa, Hirotoshi ;

Ueno, Hideki ;

Kakeji, Yoshihiro ;

Miyata, Hiroaki ;

Kitagawa, Yuko ;

Watanabe, Masahiko .

ANNALS OF GASTROENTEROLOGICAL SURGERY, 2020, 4 (06) :721-734

[3] Rectal cancer surgery: is robotic surgery supported by solid evidence? [J].

Evans, Kelsey M. ;

Sahawneh, James M. ;

Ferrara, Marco .

ANNALS OF LAPAROSCOPIC AND ENDOSCOPIC SURGERY, 2023, 8 :22-76

[4] Robotic versus laparoscopic surgery for middle and low rectal cancer (REAL): short-term outcomes of a multicentre randomised controlled trial [J].

Feng, Qingyang ;

Yuan, Weitang ;

Li, Taiyuan ;

Tang, Bo ;

Jia, Baoqing ;

Zhou, Yanbing ;

Zhang, Wei ;

Zhao, Ren ;

Zhang, Cheng ;

Cheng, Longwei ;

Zhang, Xiaoqiao ;

Liang, Fei ;

He, Guodong ;

Wei, Ye ;

Xu, Jianmin .

LANCET GASTROENTEROLOGY & HEPATOLOGY, 2022, 7 (11) :991-1004

[5] Disease-free Survival and Local Recurrence for Laparoscopic Resection Compared With Open Resection of Stage II to III Rectal Cancer Follow-up Results of the ACOSOG Z6051 Randomized Controlled Trial [J].

Fleshman, James ;

Branda, Megan E. ;

Sargent, Daniel J. ;

Boller, Anne Marie ;

George, Virgilio V. ;

Abbas, Maher A. ;

Peters, Walter R., Jr. ;

Maun, Dipen C. ;

Chang, George J. ;

Herline, Alan ;

Fichera, Alessandro ;

Mutch, Matthew G. ;

Wexner, Steven D. ;

Whiteford, Mark H. ;

Marks, John ;

Birnbaum, Elisa ;

Margolin, David A. ;

Larson, David W. ;

Marcello, Peter W. ;

Posner, Mitchell C. ;

Read, Thomas E. ;

Monson, John R. T. ;

Wren, Sherry M. ;

Pisters, Peter W. T. ;

Nelson, Heidi .

ANNALS OF SURGERY, 2019, 269 (04) :589-595

[6] Effect of Laparoscopic-Assisted Resection vs Open Resection of Stage II or III Rectal Cancer on Pathologic Outcomes The ACOSOG Z6051 Randomized Clinical Trial [J].

Fleshman, James ;

Branda, Megan ;

Sargent, Daniel J. ;

Boller, Anne Marie ;

George, Virgilio ;

Abbas, Maher ;

Peters, Walter R., Jr. ;

Maun, Dipen ;

Chang, George ;

Herline, Alan ;

Fichera, Alessandro ;

Mutch, Matthew ;

Wexner, Steven ;

Whiteford, Mark ;

Marks, John ;

Birnbaum, Elisa ;

Margolin, David ;

Larson, David ;

Marcello, Peter ;

Posner, Mitchell ;

Read, Thomas ;

Monson, John ;

Wren, Sherry M. ;

Pisters, Peter W. T. ;

Nelson, Heidi .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2015, 314 (13) :1346-1355

[7] Postoperative morbidity and mortality after mesorectal excision with and without lateral lymph node dissection for clinical stage II or stage III lower rectal cancer (JCOG0212): results from a multicentre, randomised controlled, non-inferiority trial [J].

Fujita, Shin ;

Akasu, Takayuki ;

Mizusawa, Junki ;

Saito, Norio ;

Kinugasa, Yusuke ;

Kanemitsu, Yukihide ;

Ohue, Masayuki ;

Fujii, Shoichi ;

Shiozawa, Manabu ;

Yamaguchi, Takashi ;

Moriya, Yoshihiro .

LANCET ONCOLOGY, 2012, 13 (06) :616-621

[8] Japanese Society for Cancer of the Colon and Rectum (JS']JSCCR) guidelines 2019 for the treatment of colorectal cancer [J].

Hashiguchi, Yojiro ;

Muro, Kei ;

Saito, Yutaka ;

Ito, Yoshinori ;

Ajioka, Yoichi ;

Hamaguchi, Tetsuya ;

Hasegawa, Kiyoshi ;

Hotta, Kinichi ;

Ishida, Hideyuki ;

Ishiguro, Megumi ;

Ishihara, Soichiro ;

Kanemitsu, Yukihide ;

Kinugasa, Yusuke ;

Murofushi, Keiko ;

Nakajima, Takako Eguchi ;

Oka, Shiro ;

Tanaka, Toshiaki ;

Taniguchi, Hiroya ;

Tsuji, Akihito ;

Uehara, Keisuke ;

Ueno, Hideki ;

Yamanaka, Takeharu ;

Yamazaki, Kentaro ;

Yoshida, Masahiro ;

Yoshino, Takayuki ;

Itabashi, Michio ;

Sakamaki, Kentaro ;

Sano, Keiji ;

Shimada, Yasuhiro ;

Tanaka, Shinji ;

Uetake, Hiroyuki ;

Yamaguchi, Shigeki ;

Yamaguchi, Naohiko ;

Kobayashi, Hirotoshi ;

Matsuda, Keiji ;

Kotake, Kenjiro ;

Sugihara, Kenichi .

INTERNATIONAL JOURNAL OF CLINICAL ONCOLOGY, 2020, 25 (01) :1-42

[9] Robotic versus laparoscopic surgery for rectal cancer: an overview of systematic reviews with quality assessment of current evidence [J].

Hoshino, Nobuaki ;

Sakamoto, Takashi ;

Hida, Koya ;

Sakai, Yoshiharu .

SURGERY TODAY, 2019, 49 (07) :556-570

[10] A modified method for resected specimen processing in rectal cancer: Semi-opened with transverse slicing for measuring of the circumferential resection margin [J].

Ishii, Masayuki ;

Takemasa, Ichiro ;

Okita, Kenji ;

Okuya, Koichi ;

Hamabe, Atsushi ;

Nishidate, Toshihiko ;

Akizuki, Emi ;

Sato, Yu ;

Miura, Ryo ;

Korai, Takahiro ;

Sugita, Shintaro ;

Hasegawa, Tadashi .

ASIAN JOURNAL OF ENDOSCOPIC SURGERY, 2022, 15 (02) :437-442

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