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

Phase 2
Conditions
Stomach Neoplasms
Interventions
Procedure: Laparoscopic Spleen-Preserving No.10 Lymph Node Dissections
Drug: 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
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
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
No.10 lymph node dissectionsLaparoscopic Spleen-Preserving No.10 Lymph Node DissectionsPatients 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 dissectionsoxaliplatinPatients 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
NameTimeMethod
overall postoperative morbidity rates30 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
NameTimeMethod
Numbers of No.10 lymph node dissection9 days

Numbers of dissected No.10 lymph nodes

3-year overall survival rate36 months
The variation of prealbuminPreoperative 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 rate36 months
The variation of body temperature8 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 countPreoperative 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 hemoglobinPreoperative 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 proteinPreoperative 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 node9 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 splenectomy1 days

The Rates of splenectomy are defined as the incidence of splenectomy within operation.

Intraoperative morbidity rates1 days

The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.

Time to first ambulation30 days

Time to first ambulation in hours is used to assess the postoperative recovery course.

3-year recurrence pattern36 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 flatus30 days

Time to first flatus in days is used to assess the postoperative recovery course.

Time to first liquid diet30 days

Time to first liquid diet in days is used to assess the postoperative recovery course.

Time to first soft diet30 days

Time to first soft diet in days is used to assess the postoperative recovery course.

Duration of postoperative hospital stay30 days

Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.

Postoperative pain30 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 weight3, 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 cholesterol3, 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 album3, 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 endoscopy3 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

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