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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic gastrectomy | Experimental | Laparoscopic distal subtotal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group. |
|
| Open gastrectomy | Active Comparator | Open distal subtotal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic gastrectomy | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3-year disease free survival rate | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity and mortality | The early postoperative complication and mortality are defined as the event observed within 30 days after surgery, while the time frame for late complication is the period from postoperative day 31th to the end of month 36th. | 30 days; 36 months |
| 3-year overall survival rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guoxin Li, M.D., Ph.D. | Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group; Nanfang Hospital, Southern Medical University, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital | Beijing | Beijing Municipality | 100-142 | China | ||
| The People's Liberation Army General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15650632 | Background | Huscher CG, Mingoli A, Sgarzini G, Sansonetti A, Di Paola M, Recher A, Ponzano C. Laparoscopic versus open subtotal gastrectomy for distal gastric cancer: five-year results of a randomized prospective trial. Ann Surg. 2005 Feb;241(2):232-7. doi: 10.1097/01.sla.0000151892.35922.f2. | |
| 17978289 | Background | Sakuramoto S, Sasako M, Yamaguchi T, Kinoshita T, Fujii M, Nashimoto A, Furukawa H, Nakajima T, Ohashi Y, Imamura H, Higashino M, Yamamura Y, Kurita A, Arai K; ACTS-GC Group. Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med. 2007 Nov 1;357(18):1810-20. doi: 10.1056/NEJMoa072252. |
| Label | URL |
|---|---|
| Southern Medical University, China | View source |
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|
|
| Open gastrectomy | Procedure |
|
|
|
| 36 months |
| 3-year recurrence pattern | Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type. | 36 months |
| Postoperative recovery course |
| 10 days |
| Inflammatory and immune response | The daily highest body temperature before discharge and the values of white blood cell count, hemoglobin, C-reactive protein, prealbumin and relevant immune cytokines including IL-6, T cell count, T-helper lymphocytes (CD4+) count, T-suppressor lymphocytes (CD8+) count, natural killer (NK) cells count, B-lymphocytes count, and TNF-α from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded. | 7 days |
| Beijing |
| Beijing Municipality |
| 100-853 |
| China |
| Fujian Medical University Union Hospital | Fuzhou | Fujian | 350-001 | China |
| Fujian Provincial Cancer Hospital | Fuzhou | Fujian | 350-014 | China |
| Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong | 510-515 | China |
| The Third Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510-630 | China |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150-081 | China |
| Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430022 | China |
| The Bethune First Hospital Jilin University | Changchun | Jilin | 130021 | China |
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200-025 | China |
| Zhongshan Hospital, Fudan University | Shanghai | Shanghai Municipality | 200-032 | China |
| Tangdu Hospital, the Fourth Military Medical University | Xi’an | Shanxi | 710-038 | China |
| West China Hospital, Sichuan University | Chengdu | Sichuan | 610-041 | China |
| Renji Hospital ，Shanghai Jiao Tong University School of Medicine | Shanghai | 200-127 | China |
| 20160637 | Background | Kim HH, Hyung WJ, Cho GS, Kim MC, Han SU, Kim W, Ryu SW, Lee HJ, Song KY. Morbidity and mortality of laparoscopic gastrectomy versus open gastrectomy for gastric cancer: an interim report--a phase III multicenter, prospective, randomized Trial (KLASS Trial). Ann Surg. 2010 Mar;251(3):417-20. doi: 10.1097/SLA.0b013e3181cc8f6b. |
| 20409751 | Background | Songun I, Putter H, Kranenbarg EM, Sasako M, van de Velde CJ. Surgical treatment of gastric cancer: 15-year follow-up results of the randomised nationwide Dutch D1D2 trial. Lancet Oncol. 2010 May;11(5):439-49. doi: 10.1016/S1470-2045(10)70070-X. Epub 2010 Apr 19. |
| 39937241 | Derived | Wei LH, Zheng HL, Liu ZY, Du XQ, Chen CS, Xu BB, Zheng HH, Lin GT, Xie JW, Zheng CH, Wang JB, Huang CM, Li P. Preoperative visceral fat area predicts intraoperative adverse events during lymphadenectomy in laparoscopic gastrectomy for gastric cancer: a post hoc analysis. Surg Endosc. 2025 Apr;39(4):2275-2287. doi: 10.1007/s00464-025-11602-x. Epub 2025 Feb 12. |
| 36250322 | Derived | Liu ZY, Chen QY, Zhong Q, Li P, Xie JW, Wang JB, Lin JX, Lu J, Cao LL, Lin M, Huang CM, Zheng CH. Intraoperative Adverse Events, Technical Performance, and Surgical Outcomes in Laparoscopic Radical Surgery for Gastric Cancer: A Pooled Analysis From 2 Randomized Trials. Ann Surg. 2023 Aug 1;278(2):222-229. doi: 10.1097/SLA.0000000000005727. Epub 2022 Oct 17. |
| 34668963 | Derived | Huang C, Liu H, Hu Y, Sun Y, Su X, Cao H, Hu J, Wang K, Suo J, Tao K, He X, Wei H, Ying M, Hu W, Du X, Yu J, Zheng C, Liu F, Li Z, Zhao G, Zhang J, Chen P, Li G; Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group. Laparoscopic vs Open Distal Gastrectomy for Locally Advanced Gastric Cancer: Five-Year Outcomes From the CLASS-01 Randomized Clinical Trial. JAMA Surg. 2022 Jan 1;157(1):9-17. doi: 10.1001/jamasurg.2021.5104. |
| 31630485 | Derived | Ji JF. [Chinese standard and milestone of laparoscopic surgery for gastric cancer--Comments on the publishing of "Standard Operation Procedure of Laparoscopic surgery from CLASS-01 trial"]. Zhonghua Wei Chang Wai Ke Za Zhi. 2019 Oct 25;22(10):913-915. doi: 10.3760/cma.j.issn.1671-0274.2019.10.002. Chinese. |
| 31135850 | Derived | Yu J, Huang C, Sun Y, Su X, Cao H, Hu J, Wang K, Suo J, Tao K, He X, Wei H, Ying M, Hu W, Du X, Hu Y, Liu H, Zheng C, Li P, Xie J, Liu F, Li Z, Zhao G, Yang K, Liu C, Li H, Chen P, Ji J, Li G; Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group. Effect of Laparoscopic vs Open Distal Gastrectomy on 3-Year Disease-Free Survival in Patients With Locally Advanced Gastric Cancer: The CLASS-01 Randomized Clinical Trial. JAMA. 2019 May 28;321(20):1983-1992. doi: 10.1001/jama.2019.5359. |
| Nanfang Hospital, China | View source |
| Chinese Anti-Cancer Association | View source |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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