Multicenter Study on Laparoscopic Distal Subtotal Gastrectomy for Advanced Gastric Cancer (CLASS-01)
This trial is active, not recruiting.
|Treatments||laparoscopic gastrectomy, open gastrectomy|
|Sponsor||Nanfang Hospital of Southern Medical University|
|Start date||September 2012|
|End date||December 2017|
|Trial size||1056 participants|
|Trial identifier||NCT01609309, CLASS - 01|
- 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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Beijing, China||Peking University Cancer Hospital||no longer recruiting|
|Beijing, China||The People's Liberation Army General Hospital||no longer recruiting|
|Fuzhou, China||Fujian Medical University Union Hospital||no longer recruiting|
|Fuzhou, China||Fujian Provincial Cancer Hospital||no longer recruiting|
|Guangzhou, China||Nanfang Hospital, Southern Medical University||no longer recruiting|
|Guangzhou, China||The Third Affiliated Hospital of Sun Yat-sen University||no longer recruiting|
|Harbin, China||Harbin Medical University Cancer Hospital||no longer recruiting|
|Wuhan, China||Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology||no longer recruiting|
|Changchun, China||The Bethune First Hospital Jilin University||no longer recruiting|
|Shanghai, China||Ruijin Hospital, Shanghai Jiao Tong University School of Medicine||no longer recruiting|
|Shanghai, China||Zhongshan Hospital, Fudan University||no longer recruiting|
|Xi'an, China||Tangdu Hospital, the Fourth Military Medical University||no longer recruiting|
|Chengdu, China||West China Hospital, Sichuan University||no longer recruiting|
|Shanghai, China||Renji Hospital ，Shanghai Jiao Tong University School of Medicine||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
3-year disease free survival rate
time frame: 36 months
Morbidity and mortality
time frame: 30 days; 36 months
3-year overall survival rate
time frame: 36 months
3-year recurrence pattern
time frame: 36 months
Postoperative recovery course
time frame: 10 days
Inflammatory and immune response
time frame: 7 days
Male or female participants from 19 years up to 74 years old.
Inclusion Criteria: - Age from over 18 to under 75 years - Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy - cT2-4a, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition - Expected curative resection through distal subtotal gastrectomy with D2 lymphadenectomy - Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale - ASA (American Society of Anesthesiology) score class I, II, or III - Written informed consent Exclusion Criteria: - Women during pregnancy or breast-feeding - Severe mental disorder - History of previous upper abdominal surgery (except laparoscopic cholecystectomy) - History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection - Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging - History of other malignant disease within past five years - History of previous neoadjuvant chemotherapy or radiotherapy - History of unstable angina or myocardial infarction within past six months - History of cerebrovascular accident within past six months - History of continuous systematic administration of corticosteroids within one month - Requirement of simultaneous surgery for other disease - Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer - FEV1＜50% of predicted values
|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|
|Principal investigator||Guoxin Li, M.D., Ph.D.|
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