Robotic Versus Laparoscopic Distal Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer

This study is an investigator-initiated, randomized, controlled, parallel group, and non-inferiority trial comparing robot-assisted gastrectomy with D2 nodal dissection for locally advanced gastric cancer patients with laparoscopic procedure.

Sex

All

Minimum age

20 Years

Maximum age

75 Years

Inclusion Criteria:

1. Pathologically proven gastric adenocarcinoma.
2. Tumor located in the lower third of the stomach, and is possible to be curatively resected by subtotal gastrectomy.
3. Preoperative stage of cT2-4aN0-3M0 according to American Joint Committee on Cancer/Union for International Cancer Control 8th edition
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. American Society of Anesthesiology (ASA) score of class I to III
6. Patients who freely give informed consent to participate in the clinical study

Exclusion Criteria:

1. Previous upper abdominal surgery (except laparoscopic cholecystectomy)
2. Previous gastric resection (gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection)
3. Gastric cancer-related complications (complete obstruction or perforation)
4. Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging
5. Previous neoadjuvant chemotherapy or radiotherapy for gastric cancer
6. Patients diagnosed with other malignancy within 5 years
7. Severe mental disorder
8. Unstable angina or myocardial infarction within the past 6 months
9. Cerebrovascular accident within the past 6 months
10. Severe respiratory disease (FEV1\< 50%)
11. Continuous systemic steroid therapy within 1 month before the study
12. Pregnant or breast-feeding women

• BACKGROUNDKitano S, Iso Y, Moriyama M, Sugimachi K. Laparoscopy-assisted Billroth I gastrectomy. Surg Laparosc Endosc. 1994 Apr;4(2):146-8. PMID 8180768
• BACKGROUNDZhao Y, Yu P, Hao Y, Qian F, Tang B, Shi Y, Luo H, Zhang Y. Comparison of outcomes for laparoscopically assisted and open radical distal gastrectomy with lymphadenectomy for advanced gastric cancer. Surg Endosc. 2011 Sep;25(9):2960-6. doi: 10.1007/s00464-011-1652-y. Epub 2011 Apr 22. PMID 21512884
• BACKGROUNDHu Y, Ying M, Huang C, Wei H, Jiang Z, Peng X, Hu J, Du X, Wang B, Lin F, Xu J, Dong G, Mou T, Li G; Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group. Oncologic outcomes of laparoscopy-assisted gastrectomy for advanced gastric cancer: a large-scale multicenter retrospective cohort study from China. Surg Endosc. 2014 Jul;28(7):2048-56. doi: 10.1007/s00464-014-3426-9. Epub 2014 Mar 21. PMID 24651893
• BACKGROUNDHu Y, Huang C, Sun Y, Su X, Cao H, Hu J, Xue Y, Suo J, Tao K, He X, Wei H, Ying M, Hu W, Du X, Chen P, Liu H, Zheng C, Liu F, Yu J, Li Z, Zhao G, Chen X, Wang K, Li P, Xing J, Li G. Morbidity and Mortality of Laparoscopic Versus Open D2 Distal Gastrectomy for Advanced Gastric Cancer: A Randomized Controlled Trial. J Clin Oncol. 2016 Apr 20;34(12):1350-7. doi: 10.1200/JCO.2015.63.7215. Epub 2016 Feb 22. PMID 26903580
• BACKGROUNDInaki N, Etoh T, Ohyama T, Uchiyama K, Katada N, Koeda K, Yoshida K, Takagane A, Kojima K, Sakuramoto S, Shiraishi N, Kitano S. A Multi-institutional, Prospective, Phase II Feasibility Study of Laparoscopy-Assisted Distal Gastrectomy with D2 Lymph Node Dissection for Locally Advanced Gastric Cancer (JLSSG0901). World J Surg. 2015 Nov;39(11):2734-41. doi: 10.1007/s00268-015-3160-z. PMID 26170158
• BACKGROUNDHashizume M, Shimada M, Tomikawa M, Ikeda Y, Takahashi I, Abe R, Koga F, Gotoh N, Konishi K, Maehara S, Sugimachi K. Early experiences of endoscopic procedures in general surgery assisted by a computer-enhanced surgical system. Surg Endosc. 2002 Aug;16(8):1187-91. doi: 10.1007/s004640080154. Epub 2002 May 3.