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Study on Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Advanced Gastric Cancer (CLASS-04)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02845986
Recruitment Status : Active, not recruiting
First Posted : July 27, 2016
Last Update Posted : November 13, 2017
Sponsor:
Collaborators:
Beijing Cancer Hospital
Southwest Hospital, China
Fujian Provincial Hospital
Zhangzhou Municipal Hospital of Fujian Province
Shanghai Zhongshan Hospital
Meizhou People's Hospital
Guangdong General Hospital
Guangdong Provincial Hospital of Traditional Chinese Medicine
Second Hospital of Jilin University
The First Affiliated Hospital with Nanjing Medical University
Nanfang Hospital of Southern Medical University
Affiliated Hospital of Qinghai University
The First Affiliated Hospital of Xiamen University
RenJi Hospital
West China Hospital
First Affiliated Hospital Xi'an Jiaotong University
First Affiliated Hospital of Xinjiang Medical University
The First Hospital of Putian City, Putian, Fujian
Longyan City First Hospital
Information provided by (Responsible Party):
Chang-Ming Huang, Prof., Fujian Medical University Union Hospital

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).

Condition or disease Intervention/treatment Phase
Stomach Neoplasms Procedure: Laparoscopic Spleen-Preserving No.10 Lymph Node Dissections Drug: oxaliplatin Phase 2

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 251 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2016
Actual Primary Completion Date : October 12, 2017
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Oxaliplatin

Arm Intervention/treatment
Experimental: 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.
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.
Other Name: platinum-based chemotherapy




Primary Outcome Measures :
  1. overall postoperative morbidity rates [ Time Frame: 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 :
  1. Numbers of No.10 lymph node dissection [ Time Frame: 9 days ]
    Numbers of dissected No.10 lymph nodes

  2. Rates of positive No.10 lymph node [ Time Frame: 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).

  3. 3-year overall survival rate [ Time Frame: 36 months ]
  4. 3-year disease free survival rate [ Time Frame: 36 months ]
  5. 3-year recurrence pattern [ Time Frame: 36 months ]
    Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.

  6. Rates of splenectomy [ Time Frame: 1 days ]
    The Rates of splenectomy are defined as the incidence of splenectomy within operation.

  7. Intraoperative morbidity rates [ Time Frame: 1 days ]
    The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.

  8. Time to first ambulation [ Time Frame: 30 days ]
    Time to first ambulation in hours is used to assess the postoperative recovery course.

  9. Time to first flatus [ Time Frame: 30 days ]
    Time to first flatus in days is used to assess the postoperative recovery course.

  10. Time to first liquid diet [ Time Frame: 30 days ]
    Time to first liquid diet in days is used to assess the postoperative recovery course.

  11. Time to first soft diet [ Time Frame: 30 days ]
    Time to first soft diet in days is used to assess the postoperative recovery course.

  12. Duration of postoperative hospital stay [ Time Frame: 30 days ]
    Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.

  13. Postoperative pain [ Time Frame: 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.

  14. The variation of weight [ Time Frame: 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.

  15. The variation of cholesterol [ Time Frame: 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.

  16. The variation of album [ Time Frame: 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.

  17. The results of endoscopy [ Time Frame: 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.

  18. The variation of body temperature [ Time Frame: 8 days ]
    The daily highest body temperature in degree centigrade before discharge are recorded to access the inflammatory and immune response.

  19. The variation of white blood cell count [ Time Frame: 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.

  20. The variation of hemoglobin [ Time Frame: 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.

  21. The variation of C-reactive protein [ Time Frame: 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.

  22. The variation of prealbumin [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02845986


Locations
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China, Beijing
Beijing Cancer Hospital
Haidian, Beijing, China, 100142
China, Chongqing
Southwest Hospital
Shapingba, Chongqing, China, 400038
China, Fujian
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Fujian Provincial Hospital
Fuzhou, Fujian, China, 350001
Longyan First Hospital
Longyan, Fujian, China, 364000
The First Hospital of Putian City
Putian, Fujian, China, 351100
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, China, 363000
China, Guangdong
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China, 510120
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510515
Meizhou People's Hospital
Meizhou, Guangdong, China, 514031
China, Jiangsu
Jiangsu province hospital
Nanjing, Jiangsu, China, 210029
China, Jilin
The Second Hospital of Jilin University
Changchun, Jilin, China, 130041
China, Qinghai
Qinghai University Affiliated Hospital
Xining, Qinghai, China, 810001
China, Shanghai
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Pudong, Shanghai, China, 200135
Shanghai Zhongshan Hospital
Xuhui, Shanghai, China, 200032
China, Shanxi
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shanxi, China, 710061
China, Sichuan
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
China, Xinjiang
The First Affiliated Hospital of Xinjiang Medical University
Xinjiang, Xinjiang, China, 830054
Sponsors and Collaborators
Fujian Medical University
Beijing Cancer Hospital
Southwest Hospital, China
Fujian Provincial Hospital
Zhangzhou Municipal Hospital of Fujian Province
Shanghai Zhongshan Hospital
Meizhou People's Hospital
Guangdong General Hospital
Guangdong Provincial Hospital of Traditional Chinese Medicine
Second Hospital of Jilin University
The First Affiliated Hospital with Nanjing Medical University
Nanfang Hospital of Southern Medical University
Affiliated Hospital of Qinghai University
The First Affiliated Hospital of Xiamen University
RenJi Hospital
West China Hospital
First Affiliated Hospital Xi'an Jiaotong University
First Affiliated Hospital of Xinjiang Medical University
The First Hospital of Putian City, Putian, Fujian
Longyan City First Hospital
Investigators
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Principal Investigator: Changming Huang, Professor Fujian Medical University Union Hospital,China

Publications of Results:

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Responsible Party: Chang-Ming Huang, Prof., Professor, Fujian Medical University Union Hospital
ClinicalTrials.gov Identifier: NCT02845986     History of Changes
Other Study ID Numbers: 2016-01
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data (IPD) available.

Keywords provided by Chang-Ming Huang, Prof., Fujian Medical University Union Hospital:
Stomach Neoplasms
Laparoscopy
Spleen-Preserving
No.10 Lymph Node Dissection

Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Oxaliplatin
Antineoplastic Agents