Laparoscopic Versus Open Gastrectomy With Splenic Hilum Lymph Nodes Dissection

Overview

Splenic hilum remains challenging during total gastrectomy with D2 lymphadenectomy.The application of minimally invasive surgery for advanced gastric cancer is gaining popularity. The investigators aim to compare the safety and feasibility of LTG and OTG for advanced proximal gastric cancer.

Full Title of Study: “Laparoscopic Versus Open Total Gastrectomy With Spleen-preserving Splenic Hilum Lymph Nodes Dissection for Advanced Proximal Gastric Cancer: A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2019

Detailed Description

Total gastrectomy with D2 lymphadenectomy remains the standard surgical therapy for patients with advanced proximal gastric cancer. Although lymph nodes dissection along with the splenic hilum (No.10) is recommended by the Japanese Gastric Cancer Treatment Guidelines, however, complete removal of the No. 10 is technically challenging due to the tortuous splenic vessels and the high possibility of injury to the parenchyma of the spleen and pancreas. Recently, the application of minimally invasive surgery for advanced gastric cancer is gaining popularity. However, laparoscopic total gastrectomy (LTG) with standard D2 lymphadenectomy was still not widely performed, because pancreas- and spleen-preserving splenic hilum lymph node dissection were mainly challenging manipulations for laparoscopic surgeons. Therefore,the investigators aim to investigate the safety and feasibility of LTG with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer and compare the early results of this procedure with open total gastrectomy (OTG).

Interventions

  • Procedure: Laparoscopic total gastrectomy
    • When the participants with advanced proximal gastric cancer are randomized in the laparoscopic totalgastrectomy (LATG) group, they will received LTG with spleen-preserving splenic hilum lymph nodes dissection.
  • Procedure: Open total gastrectomy
    • When the participants with advanced proximal gastric cancer are randomized in the open total gastrectomy(OTG) group, they will received OTG with spleen-preserving splenic hilum lymph nodes dissection.

Arms, Groups and Cohorts

  • Experimental: Laparoscopic total gastrectomy
    • Participants including in the laparoscopic total gastrectomy (LTG) group will undergo LTG with spleen-preserving splenic hilum lymph nodes dissection.
  • Active Comparator: Open total gastrectomy
    • Participants who are included in the open total gastrectomy (OTG) group will OTG with spleen-preserving splenic hilum lymph nodes dissection.

Clinical Trial Outcome Measures

Primary Measures

  • Number of group Splenic Hilum (No.10) lymph nodes harvested
    • Time Frame: 7 days

Secondary Measures

  • Early complication rate
    • Time Frame: 30 days
    • The early complication rate is defined as the event observed during operation
  • Operative time
    • Time Frame: Intraoperative
  • Operative blood loss
    • Time Frame: Intraoperative
  • Time of splenic hilum lymph nodes dissection
    • Time Frame: Intraoperative
  • Number of total lymph nodes harvested
    • Time Frame: 7 days
  • Post-operative recovery course
    • Time Frame: 30 days
    • Time to first ambulation, flatus, liquid diet and duration of hospital stay are used to assess the postoperative recovery course
  • 3-year disease free survival rate
    • Time Frame: 3 years
  • 3-year overall survival rate
    • Time Frame: 3 years
  • Quality of life
    • Time Frame: 1 year
    • It will be assessed by questionnaire (WHO quality of life-100)

Participating in This Clinical Trial

Inclusion Criteria

1. Primary proximal gastric adenocarcinoma confirmed pathologically by endoscopic biopsy; 2. cT2-4aN0-3M0 at preoperative evaluation according to American Joint Committee On Cancer (AJCC) Cancer Staging Manual, 7th Edition. 3. Eastern Cooperative Oncology Group (ECOG): 0 or 1; 4. American Society of Anesthesiologists (ASA) score: Ⅰto Ⅲ; 5. Written informed consent. Exclusion Criteria:

1. Pregnant or breast-feeding women; 2. Severe mental disorder; 3. Previous upper abdominal surgery (except laparoscopic cholecystectomy); 4. Previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection; 5. Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging; 6. Other malignant disease within the past 5 years; 7. Previous neoadjuvant chemotherapy or radiotherapy; 8. Contraindication to general anesthesia (severe cardiac and/or pulmonary disease); 9. Emergency surgery due to a complication (bleeding, obstruction, or perforation) caused by gastric cancer.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chinese PLA General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Lin Chen, Director – Chinese PLA General Hospital
  • Overall Official(s)
    • Lin Chen, Principal Investigator, the Chinese PLA General Hospital
  • Overall Contact(s)
    • Hongqing Xi, Master, 010-66938128

References

Bian S, Xi H, Wu X, Cui J, Ma L, Chen R, Wei B, Chen L. The Role of No. 10 Lymphadenectomy for Advanced Proximal Gastric Cancer Patients Without Metastasis to No. 4sa and No. 4sb Lymph Nodes. J Gastrointest Surg. 2016 Jul;20(7):1295-304. doi: 10.1007/s11605-016-3113-3. Epub 2016 Mar 3.

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