Study on Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Advanced Gastric Cancer
- Conditions
- Stomach Neoplasms
- Interventions
- Procedure: Laparoscopic Spleen-Preserving No.10 Lymph Node DissectionsDrug: oxaliplatin
- Registration Number
- NCT02845986
- Lead Sponsor
- Fujian Medical University
- 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 251
- Age between 18 to 75 years old
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- 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)
- No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations
- Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
- ASA (American Society of Anesthesiology) class I to III
- Written informed consent
- Pregnant and lactating women
- Suffering from severe mental disorder
- History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
- History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer)
- Enlarged or bulky regional lymph node (diameter over 3cm)supported by preoperative imaging including enlarged or bulky No.10 lymph node
- History of other malignant disease within the past 5 years
- History of previous neoadjuvant chemotherapy or radiotherapy
- History of unstable angina or myocardial infarction within the past 6 months
- History of cerebrovascular accident within the past 6 months
- History of continuous systematic administration of corticosteroids within 1 month
- Requirement of simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- FEV1<50% of the predicted values
- Splenectomy must be performed due to the obvious tumor invasion in spleen or spleen blood vessels.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description No.10 lymph node dissections Laparoscopic Spleen-Preserving No.10 Lymph Node Dissections Patients with locally advanced upper third gastric carcinoma will performed laparoscopic spleen-preserving No.10 lymph node dissections.After the surgery the patients will be treated with oxaliplatin or platinum-based chemotherapy. No.10 lymph node dissections oxaliplatin Patients with locally advanced upper third gastric carcinoma will performed laparoscopic spleen-preserving No.10 lymph node dissections.After the surgery the patients will be treated with oxaliplatin or platinum-based chemotherapy.
- Primary Outcome Measures
Name Time Method overall postoperative morbidity rates 30 days Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.
- Secondary Outcome Measures
Name Time Method Numbers of No.10 lymph node dissection 9 days Numbers of dissected No.10 lymph nodes
3-year overall survival rate 36 months The variation of prealbumin Preoperative 3 days and postoperative 1, 3, and 5 days The values of prealbumin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
3-year disease free survival rate 36 months The variation of body temperature 8 days The daily highest body temperature in degree centigrade before discharge are recorded to access the inflammatory and immune response.
The variation of white blood cell count Preoperative 3 days and postoperative 1, 3, and 5 days The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
The variation of hemoglobin Preoperative 3 days and postoperative 1, 3, and 5 days The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
The variation of C-reactive protein Preoperative 3 days and postoperative 1, 3, and 5 days The values of C-reactive protein IN milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
Rates of positive No.10 lymph node 9 days The Rates of positive No.10 lymph node are defined as the incidence of positive No.10 lymph node (divide number of positive No.10 lymph nodes by number of total No.10 lymph nodes).
Rates of splenectomy 1 days The Rates of splenectomy are defined as the incidence of splenectomy within operation.
Intraoperative morbidity rates 1 days The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
Time to first ambulation 30 days Time to first ambulation in hours is used to assess the postoperative recovery course.
3-year recurrence pattern 36 months Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.
Time to first flatus 30 days Time to first flatus in days is used to assess the postoperative recovery course.
Time to first liquid diet 30 days Time to first liquid diet in days is used to assess the postoperative recovery course.
Time to first soft diet 30 days Time to first soft diet in days is used to assess the postoperative recovery course.
Duration of postoperative hospital stay 30 days Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
Postoperative pain 30 days Visual analog pain score method is used to evaluate the difference of postoperative pain degree.The score of postoperative pain is used to assess the postoperative recovery course.
The variation of weight 3, 6, 9 and 12 months The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
The variation of cholesterol 3, 6, 9 and 12 months The variation of cholesterol in millimole/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
The variation of album 3, 6, 9 and 12 months The variation of album in gram/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
The results of endoscopy 3 and 12 months The incidence of reflux esophagitis under the endoscopy on postoperative 3 and 12 months are used to access the postoperative quality of life.
Trial Locations
- Locations (20)
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
Fujian Provincial Hospital
🇨🇳Fuzhou, Fujian, China
Longyan First Hospital
🇨🇳Longyan, Fujian, China
The First Hospital of Putian City
🇨🇳Putian, Fujian, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
Zhangzhou Municipal Hospital of Fujian Province
🇨🇳Zhangzhou, Fujian, China
Southwest Hospital
🇨🇳Shapingba, Chongqing, China
Guangdong General Hospital
🇨🇳Guangzhou, Guangdong, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
🇨🇳Guangzhou, Guangdong, China
Meizhou People's Hospital
🇨🇳Meizhou, Guangdong, China
The Second Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Qinghai University Affiliated Hospital
🇨🇳Xining, Qinghai, China
Renji Hospital, Shanghai Jiao Tong University School of Medicine
🇨🇳Pudong, Shanghai, China
Shanghai Zhongshan Hospital
🇨🇳Xuhui, Shanghai, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
The First Affiliated Hospital of Xinjiang Medical University
🇨🇳Xinjiang, Xinjiang, China
Beijing Cancer Hospital
🇨🇳Haidian, Beijing, China
Jiangsu province hospital
🇨🇳Nanjing, Jiangsu, China
Nanfang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China