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

Stomach Neoplasms Clinical Trial

— CLASS-04  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02845986
• Other study ID #: 2016-01
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 1, 2016
• Est. completion date: October 12, 2020

Study information

• Verified date: February 2020
• Source: Fujian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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）.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 251
• Est. completion date: October 12, 2020
• Est. primary completion date: October 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

Procedure:
• Laparoscopic Spleen-Preserving No.10 Lymph Node Dissections
After exclusion of T4b, bulky lymph nodes, or distant metastasis case et al. Laparoscopic spleen-preserving No.10 lymph node dissections will be performed with curative treated intent in patients with locally advanced upper third gastric adenocarcinoma.

Drug:
• oxaliplatin
oxaliplatin or platinum-based chemotherapy is used when the patients undergo adjuvant chemotherapy after the surgery.

Locations

Country	Name	City	State
China	The Second Hospital of Jilin University	Changchun	Jilin
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Fujian Provincial Hospital	Fuzhou	Fujian
China	Guangdong General Hospital	Guangzhou	Guangdong
China	Guangdong Provincial Hospital of Traditional Chinese Medicine	Guangzhou	Guangdong
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong
China	Beijing Cancer Hospital	Haidian	Beijing
China	Longyan First Hospital	Longyan	Fujian
China	Meizhou People's Hospital	Meizhou	Guangdong
China	Jiangsu province hospital	Nanjing	Jiangsu
China	Renji Hospital, Shanghai Jiao Tong University School of Medicine	Pudong	Shanghai
China	The First Hospital of Putian City	Putian	Fujian
China	Southwest Hospital	Shapingba	Chongqing
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	Qinghai University Affiliated Hospital	Xining	Qinghai
China	The First Affiliated Hospital of Xinjiang Medical University	Xinjiang	Xinjiang
China	Shanghai Zhongshan Hospital	Xuhui	Shanghai
China	Zhangzhou Municipal Hospital of Fujian Province	Zhangzhou	Fujian

Sponsors (20)

Lead Sponsor

Collaborator

Fujian Medical University

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

Country where clinical trial is conducted

China, 

References & Publications (22)

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Huang CM, Chen QY, Lin JX, Zheng CH, Li P, Xie JW. Huang's three-step maneuver for laparoscopic spleen-preserving No. 10 lymph node dissection for advanced proximal gastric cancer. Chin J Cancer Res. 2014 Apr;26(2):208-10. doi: 10.3978/j.issn.1000-9604.20 — View Citation

Hur H, Jeon HM, Kim W. Laparoscopic pancreas- and spleen-preserving D2 lymph node dissection in advanced (cT2) upper-third gastric cancer. J Surg Oncol. 2008 Feb 1;97(2):169-72. — View Citation

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall postoperative morbidity rates	Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.	30 days
Secondary	Numbers of No.10 lymph node dissection	Numbers of dissected No.10 lymph nodes	9 days
Secondary	Rates of positive No.10 lymph node	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).	9 days
Secondary	3-year overall survival rate		36 months
Secondary	3-year disease free survival rate		36 months
Secondary	3-year recurrence pattern	Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.	36 months
Secondary	Rates of splenectomy	The Rates of splenectomy are defined as the incidence of splenectomy within operation.	1 days
Secondary	Intraoperative morbidity rates	The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.	1 days
Secondary	Time to first ambulation	Time to first ambulation in hours is used to assess the postoperative recovery course.	30 days
Secondary	Time to first flatus	Time to first flatus in days is used to assess the postoperative recovery course.	30 days
Secondary	Time to first liquid diet	Time to first liquid diet in days is used to assess the postoperative recovery course.	30 days
Secondary	Time to first soft diet	Time to first soft diet in days is used to assess the postoperative recovery course.	30 days
Secondary	Duration of postoperative hospital stay	Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.	30 days
Secondary	Postoperative pain	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.	30 days
Secondary	The variation of weight	The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.	3, 6, 9 and 12 months
Secondary	The variation of cholesterol	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.	3, 6, 9 and 12 months
Secondary	The variation of album	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.	3, 6, 9 and 12 months
Secondary	The results of endoscopy	The incidence of reflux esophagitis under the endoscopy on postoperative 3 and 12 months are used to access the postoperative quality of life.	3 and 12 months
Secondary	The variation of body temperature	The daily highest body temperature in degree centigrade before discharge are recorded to access the inflammatory and immune response.	8 days
Secondary	The variation of white blood cell count	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.	Preoperative 3 days and postoperative 1, 3, and 5 days
Secondary	The variation of hemoglobin	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.	Preoperative 3 days and postoperative 1, 3, and 5 days
Secondary	The variation of C-reactive protein	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.	Preoperative 3 days and postoperative 1, 3, and 5 days
Secondary	The variation of prealbumin	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.	Preoperative 3 days and postoperative 1, 3, and 5 days