Spots Global Cancer Trial Database for Multicenter Study on Laparoscopic Distal Subtotal Gastrectomy for Advanced Gastric Cancer (CLASS-01)
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Trial Identification
Brief Title: Multicenter Study on Laparoscopic Distal Subtotal Gastrectomy for Advanced Gastric Cancer (CLASS-01)
Official Title: Multicenter Study on Comparison of Long-term Outcome Between Laparoscopic and Open Distal Subtotal Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer
Study ID: NCT01609309
Conditions
Study Description
Brief Summary: * Laparoscopic distal subtotal gastrectomy with lymph node dissection as minimally invasive surgery has gained popularity for the treatment of early gastric cancer in East Asian countries, even though the long-term follow-up outcome based on multicenter randomized clinical trial (RCT) is still awaited. * For the patient with locally advanced gastric cancer, several studies indicated that laparoscopic distal subtotal gastrectomy with D2 lymphadenectomy is a technically feasible and safe procedure by experienced surgeons in high-volume specialized hospitals. However, the application of it is controversial mainly due to lack of solid evidence on the oncologic efficacy. Therefore, conventional open approach is still the current standard for advanced gastric cancer. * Nowadays, the proportion of patients with locally advanced gastric cancer is estimated up to 80 per cent of all gastric cancer cases in China. Before the clinical application of laparoscopic procedure for the treatment with curative intent to advanced gastric cancer located at the middle- or lower-third of the stomach, the oncologic efficacy must be verified. * Accordingly,the comparison of intraoperative and postoperative complications between laparoscopic and open distal subtotal gastrectomy for over 65 years old patients with gastric cancer based on a randomized controlled trial is needed.
Detailed Description:
Keywords
Eligibility
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Peking University Cancer Hospital, Beijing, Beijing, China
The People's Liberation Army General Hospital, Beijing, Beijing, China
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
Fujian Provincial Cancer Hospital, Fuzhou, Fujian, China
Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China
The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China
Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
The Bethune First Hospital Jilin University, Changchun, Jilin, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China
Zhongshan Hospital, Fudan University, Shanghai, Shanghai, China
Tangdu Hospital, the Fourth Military Medical University, Xi'an, Shanxi, China
West China Hospital, Sichuan University, Chengdu, Sichuan, China
Renji Hospital ，Shanghai Jiao Tong University School of Medicine, Shanghai, , China
Contact Details
Name: Guoxin Li, M.D., Ph.D.
Affiliation: Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group; Nanfang Hospital, Southern Medical University, China
Role: PRINCIPAL_INVESTIGATOR
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