Study on Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Advanced Gastric Cancer

• Status: Active, not recruiting
• Trial end date: 2020-10-12
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to explore the safety and feasibility of the Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for patients with locally advanced upper third gastric adenocarcinoma（cT2-4a, N-/+, M0）.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fujian Medical University
• Collaborators: Affiliated Hospital of Qinghai University; Beijing Cancer Hospital; First Affiliated Hospital of Xinjiang Medical University; First Affiliated Hospital Xi'an Jiaotong University; Fujian Provincial Hospital; Guangdong Provincial Hospital of Traditional Chinese Medicine; Guangdong Provincial People's Hospital; Longyan City First Hospital; Meizhou People's Hospital; Nanfang Hospital of Southern Medical University; RenJi Hospital; Second Hospital of Jilin University; Shanghai Zhongshan Hospital; Southwest Hospital, China; The First Affiliated Hospital of Xiamen University; The First Affiliated Hospital with Nanjing Medical University; The First Hospital of Putian City, Putian, Fujian; West China Hospital; Zhangzhou Municipal Hospital of Fujian Province
• Treatments: Oxaliplatin

Criteria

Inclusion Criteria:

1. Age between 18 to 75 years old

2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy

3. Locally advanced tumor in the upper third stomach（cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC(American Joint Committee on Cancer) Cancer Staging Manual Seventh Edition）

4. No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations

5. Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale

6. ASA (American Society of Anesthesiology) class I to III

7. Written informed consent

Exclusion Criteria:

1. Pregnant and lactating women

2. Suffering from severe mental disorder

3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)

4. History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer)

5. Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging including enlarged or bulky No.10 lymph node

6. History of other malignant disease within the past 5 years

7. History of previous neoadjuvant chemotherapy or radiotherapy

8. History of unstable angina or myocardial infarction within the past 6 months

9. History of cerebrovascular accident within the past 6 months

10. History of continuous systematic administration of corticosteroids within 1 month

11. Requirement of simultaneous surgery for other disease

12. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer

13. FEV1<50% of the predicted values

14. Splenectomy must be performed due to the obvious tumor invasion in spleen or spleen blood vessels.