Clinical trial NCT02845986: Study on Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Advanced Gastric Cancer
Official title: Safety and Feasibility of Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Locally Advanced Upper Third Gastric Cancer: A Multicenter Phase II Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stomach Neoplasms
Keywords: Stomach Neoplasms
Laparoscopy
Spleen-Preserving
No.10 Lymph Node Dissection
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
Collaborators: name: Peking University Cancer Hospital & Institute
name: Southwest Hospital, China
name: Fujian Provincial Hospital
name: Zhangzhou Municipal Hospital of Fujian Province
name: Shanghai Zhongshan Hospital
name: Meizhou People's Hospital
name: Guangdong Provincial People's Hospital
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Second Hospital of Jilin University
name: The First Affiliated Hospital with Nanjing Medical University
name: Nanfang Hospital, Southern Medical University
name: Affiliated Hospital of Qinghai University
name: The First Affiliated Hospital of Xiamen University
name: RenJi Hospital
name: West China Hospital
name: First Affiliated Hospital Xi'an Jiaotong University
name: First Affiliated Hospital of Xinjiang Medical University
name: The First Hospital of Putian City, Putian, Fujian
name: Longyan City First Hospital
First posted: 2016-07-27
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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）.

Detailed description: Radical resection is still the primary method of treating advanced gastric cancer.According to the Japanese treatment guidelines for gastric cancer, D2 lymphadenectomy, including No. 10 lymph node dissection, should be adopted for upper third gastric carcinoma.The incidence of No. 10 lymph node metastasis is high in advanced proximal gastric cancer, reported to range from 9.8%-20.9%, and the presence of No. 10 lymph node metastasis is closely related to survival. Therefore, in East Asia, D2 lymph node dissection of potentially curable locally advanced upper third gastric cancer including No. 10 lymph node is the standard surgical treatment.

In the early, splenectomy was performed to remove No. 10 lymph node. With the improvement of medical knowledge and surgical technique, spleen-preserving No. 10 lymph node dissection has been recognized by more and more surgeons. However, due to the special and complex anatomy of the spleen, spleen-preserving No. 10 lymph node dissection is difficult, even in open surgery; consequently, the surgery cannot be performed in many centers.

Laparoscopic surgery has distinct minimally invasive advantages, such as small incisions, less blood loss, less postoperative pain, mild postoperative inflammatory reactions, a quick recovery of gastrointestinal function, shorter hospital stays and obvious cosmetic effects. Since Kitano et al. first reported laparoscopic gastrectomy for gastric cancer in 1994, laparoscopic techniques have developed rapidly. The techniques are becoming increasingly mature, making it possible to perform laparoscopic spleen-preserving No. 10 lymph node dissection. Our center first proposed "Huang's three-step maneuver", a new operative method suitable for laparoscopic spleen-preserving No. 10 lymph node dissection. This method simplifies the procedure of laparoscopic spleen-preserving No. 10 lymph node dissection and facilitates its popularization and promotion.

However, it remains a controversial international issue if it is safe and feasible to routinely conduct laparoscopic spleen-preserving No. 10 lymph node dissection for advanced upper third gastric cancer.A number of retrospective studies have successively confirmed the safety, feasibility and oncological efficacy of laparoscopic spleen-preserving No. 10 lymph node dissection.But there is no multicenter prospective studies to identify the results.

Therefore, The study is through a prospective, multicenter, open, single-arm, non-inferiority study,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）.

Eligibility 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.

Primary outcomes:
measure: overall postoperative morbidity rates
timeFrame: 30 days
Secondary outcomes:
measure: Numbers of No.10 lymph node dissection
timeFrame: 9 days
measure: Rates of positive No.10 lymph node
timeFrame: 9 days
measure: 3-year overall survival rate
timeFrame: 36 months
measure: 3-year disease free survival rate
timeFrame: 36 months
measure: 3-year recurrence pattern
timeFrame: 36 months
measure: Rates of splenectomy
timeFrame: 1 days
measure: Intraoperative morbidity rates
timeFrame: 1 days
measure: Time to first ambulation
timeFrame: 30 days
measure: Time to first flatus
timeFrame: 30 days
measure: Time to first liquid diet
timeFrame: 30 days
measure: Time to first soft diet
timeFrame: 30 days
measure: Duration of postoperative hospital stay
timeFrame: 30 days
measure: Postoperative pain
timeFrame: 30 days
measure: The variation of weight
timeFrame: 3, 6, 9 and 12 months
measure: The variation of cholesterol
timeFrame: 3, 6, 9 and 12 months
measure: The variation of album
timeFrame: 3, 6, 9 and 12 months
measure: The results of endoscopy
timeFrame: 3 and 12 months
measure: The variation of body temperature
timeFrame: 8 days
measure: The variation of white blood cell count
timeFrame: Preoperative 3 days and postoperative 1, 3, and 5 days
measure: The variation of hemoglobin
timeFrame: Preoperative 3 days and postoperative 1, 3, and 5 days
measure: The variation of C-reactive protein
timeFrame: Preoperative 3 days and postoperative 1, 3, and 5 days
measure: The variation of prealbumin
timeFrame: Preoperative 3 days and postoperative 1, 3, and 5 days
Other outcomes:
Locations:
city: Haidian
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Shapingba
country: China
facility: Southwest Hospital
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
city: Longyan
country: China
facility: Longyan First Hospital
state: Fujian
city: Putian
country: China
facility: The First Hospital of Putian City
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Zhangzhou
country: China
facility: Zhangzhou Municipal Hospital of Fujian Province
state: Fujian
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Traditional Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
city: Meizhou
country: China
facility: Meizhou People's Hospital
state: Guangdong
city: Nanjing
country: China
facility: Jiangsu province hospital
state: Jiangsu
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Xining
country: China
facility: Qinghai University Affiliated Hospital
state: Qinghai
city: Pudong
country: China
facility: Renji Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Xuhui
country: China
facility: Shanghai Zhongshan Hospital
state: Shanghai
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Xinjiang
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
Study officials:
affiliation: Fujian Medical University Union Hospital,China
name: Changming Huang, Professor
role: PRINCIPAL_INVESTIGATOR
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