Robotic Versus Laparoscopic Distal Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer
NCT ID: NCT03273920
Last Updated: 2017-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1110 participants
INTERVENTIONAL
2017-09-25
2022-09-25
Brief Summary
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Detailed Description
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To minimize the limitations of laparoscopic surgery, robot systems have been introduced to treat GC providing technical advantages. Though the feasibility and safety of robotic gastrectomy (RG) have been well accepted, the benefits of RG remain controversial. A recent meta-analysis including eleven studies of 3503 patients demonstrated that RG indicated potentially favorable outcomes in terms of blood loss compared with LG. Furthermore, it has been confirmed that robotic system could provide an advantage over LG in the dissection of the N2 area lymph nodes, especially around the splenic artery area. Our previous study demonstrated that the RG had less intraoperative blood loss and more lymph nodes dissection compared with the laparoscopic procedure. However, the only prospective study reported that RG is not superior to LG in terms of perioperative surgical outcomes. Nevertheless, the following subgroup analysis found that patients with GC undergoing D2 lymph node dissection can benefit from less blood loss when a robotic surgery system is used. Take together, RG with D2 nodal dissection may be superior laparoscopic surgery in terms of blood loss and retrieved lymph nodes. However, lack of high-level evidence-based medical researches, we can't drew a conclusion that patients with AGC may benefit from RG with D2 nodal dissection.
With regard to a new surgical approach, oncologic safety has attracted more attention. Although some retrospective studies have demonstrated that RG with lymphadenectomy for GC had non-inferior oncologic outcome relative to LG, there is no prospective RCT to evaluate the long-term outcomes of RG. Therefore, the Chinese Robotic Gastrointestinal Surgery Study (CRASS) Group launched a multicenter prospective RCT to verify the short-term and long-term outcomes of RG in AGC. The primary objective of this study is to assess whether robot-assisted distal gastrectomy is comparable to laparoscopic approach in terms of long-term oncologic outcomes without compromising relapse-free survival. The secondary research objectives are to compare robotic and laparoscopic approach in terms of morbidity, mortality, quality of life, cost-effectiveness, and overall survival.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Robotic gastrectomy
Robotic distal gastrectomy with D2 nodal dissection
Robotic distal gastrectomy with D2 nodal dissection
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, robotic distal gastrectomy with D2 lymph node dissection will be performed with curative treated intent.The type of reconstruction will be determined by the surgeon's experience and preference. The reconstruction can be carried out by extracorporeal or intracorporeal anastomosis.
Laparoscopic gastrectomy
Laparoscopic distal gastrectomy with D2 nodal dissection
Laparoscopic distal gastrectomy with D2 nodal dissection
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, laparoscopic distal gastrectomy with D2 lymph node dissection will be performed with curative treated intent.The type of reconstruction will be determined by the surgeon's experience and preference. The reconstruction can be carried out by extracorporeal or intracorporeal anastomosis.
Interventions
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Robotic distal gastrectomy with D2 nodal dissection
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, robotic distal gastrectomy with D2 lymph node dissection will be performed with curative treated intent.The type of reconstruction will be determined by the surgeon's experience and preference. The reconstruction can be carried out by extracorporeal or intracorporeal anastomosis.
Laparoscopic distal gastrectomy with D2 nodal dissection
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, laparoscopic distal gastrectomy with D2 lymph node dissection will be performed with curative treated intent.The type of reconstruction will be determined by the surgeon's experience and preference. The reconstruction can be carried out by extracorporeal or intracorporeal anastomosis.
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
75 Years
ALL
No
Sponsors
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Chinese PLA General Hospital
OTHER
West China Hospital
OTHER
Xijing Hospital of Digestive Diseases
OTHER
Nanjing PLA General Hospital
OTHER
Peking University Cancer Hospital & Institute
OTHER
Qingdao University
OTHER
Fujian Medical University Union Hospital
OTHER
Central South University
OTHER
The First Affiliated Hospital of Nanchang University
OTHER
Sun Yat-sen University
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Jilin Provincial Tumor Hospital
OTHER
Lanzhou General Hospital of PLA
OTHER
Southwest Hospital, China
OTHER
Responsible Party
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Yan Shi
Deputy director
Principal Investigators
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Peiwu Yu, M.D.
Role: STUDY_CHAIR
Southwest Hospital, China
Locations
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Chinese PLA general hospital
Beijing, Beijing Municipality, China
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Department of General Surgery and Center of Microinvasive Gastrointestinal Surgery, Southwest Hospital
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Lanzhou PLA General Hospital
Lanzhou, Gansu, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Nanjing General Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Jilin Cancer Hospital
Changchun, Jilin, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Xijing Hospital of Digestive Dieases
Xi’an, Shanxi, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Lin Chen, M.D.
Role: primary
Xiangqian Su, M.D.
Role: primary
Changmin Huang, M.D.
Role: primary
Hongbin Liu, M.D.
Role: primary
Zhiwei Zhou, M.D.
Role: primary
Kaixiong Tao, M.D.
Role: primary
Hongliang Yao, M.D.
Role: primary
Zhiwei Jiang, M.D.
Role: primary
Taiyuan Li, M.D.
Role: primary
Longwei Cheng, M.D.
Role: primary
Yanbing Zhou, M.D.
Role: primary
Jipeng Li, M.D.
Role: primary
Jiankun Hu, M.D.
Role: primary
References
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Kitano S, Iso Y, Moriyama M, Sugimachi K. Laparoscopy-assisted Billroth I gastrectomy. Surg Laparosc Endosc. 1994 Apr;4(2):146-8.
Zhao 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.
Hu 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.
Hu 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.
Inaki 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.
Hashizume 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.
Junfeng Z, Yan S, Bo T, Yingxue H, Dongzhu Z, Yongliang Z, Feng Q, Peiwu Y. Robotic gastrectomy versus laparoscopic gastrectomy for gastric cancer: comparison of surgical performance and short-term outcomes. Surg Endosc. 2014 Jun;28(6):1779-87. doi: 10.1007/s00464-013-3385-6. Epub 2014 Jan 3.
Nakauchi M, Suda K, Susumu S, Kadoya S, Inaba K, Ishida Y, Uyama I. Comparison of the long-term outcomes of robotic radical gastrectomy for gastric cancer and conventional laparoscopic approach: a single institutional retrospective cohort study. Surg Endosc. 2016 Dec;30(12):5444-5452. doi: 10.1007/s00464-016-4904-z. Epub 2016 Apr 29.
Obama K, Kim YM, Kang DR, Son T, Kim HI, Noh SH, Hyung WJ. Long-term oncologic outcomes of robotic gastrectomy for gastric cancer compared with laparoscopic gastrectomy. Gastric Cancer. 2018 Mar;21(2):285-295. doi: 10.1007/s10120-017-0740-7. Epub 2017 Jun 21.
Duan BS, Zhao J, Xie LF, Wang Y. Robotic Verse Laparoscopic Gastrectomy for Gastric Cancer: A Pooled Analysis of 11 Individual Studies. Surg Laparosc Endosc Percutan Tech. 2017 Jun;27(3):147-153. doi: 10.1097/SLE.0000000000000410.
Kim HI, Han SU, Yang HK, Kim YW, Lee HJ, Ryu KW, Park JM, An JY, Kim MC, Park S, Song KY, Oh SJ, Kong SH, Suh BJ, Yang DH, Ha TK, Kim YN, Hyung WJ. Multicenter Prospective Comparative Study of Robotic Versus Laparoscopic Gastrectomy for Gastric Adenocarcinoma. Ann Surg. 2016 Jan;263(1):103-9. doi: 10.1097/SLA.0000000000001249.
Park JM, Kim HI, Han SU, Yang HK, Kim YW, Lee HJ, An JY, Kim MC, Park S, Song KY, Oh SJ, Kong SH, Suh BJ, Yang DH, Ha TK, Hyung WJ, Ryu KW. Who may benefit from robotic gastrectomy?: A subgroup analysis of multicenter prospective comparative study data on robotic versus laparoscopic gastrectomy. Eur J Surg Oncol. 2016 Dec;42(12):1944-1949. doi: 10.1016/j.ejso.2016.07.012. Epub 2016 Jul 29.
Other Identifiers
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CRASS-01
Identifier Type: -
Identifier Source: org_study_id
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