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Laparoscopic Versus Open Gastrectomy With Splenic Hilum Lymph Nodes Dissection

This study is not yet open for participant recruitment.
Verified December 2016 by Lin Chen, Chinese PLA General Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02980861
First Posted: December 2, 2016
Last Update Posted: December 6, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Lin Chen, Chinese PLA General Hospital
  Purpose
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.

Condition Intervention Phase
Gastric Cancer Procedure: Laparoscopic total gastrectomy Procedure: Open total gastrectomy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laparoscopic Versus Open Total Gastrectomy With Spleen-preserving Splenic Hilum Lymph Nodes Dissection for Advanced Proximal Gastric Cancer: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Lin Chen, Chinese PLA General Hospital:

Primary Outcome Measures:
  • Number of group Splenic Hilum (No.10) lymph nodes harvested [ Time Frame: 7 days ]

Secondary Outcome 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)


Estimated Enrollment: 200
Study Start Date: January 2017
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laparoscopic total gastrectomy
Participants including in the laparoscopic total gastrectomy (LTG) group will undergo LTG with spleen-preserving splenic hilum lymph nodes dissection.
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.
Other Name: LTG
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.
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.
Other Name: OTG

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).
  Eligibility

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

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.
  Contacts and Locations
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): NCT02980861


Contacts
Contact: Hongqing Xi, Master 010-66938128

Locations
China
Chinese PLA General Hospital Not yet recruiting
Beijing, China, 100853
Contact: Lin Chen, Master    86-13801290395    chenlinbj@sina.com   
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
Principal Investigator: Lin Chen the Chinese PLA General Hospital
  More Information

Publications:
Responsible Party: Lin Chen, Director, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02980861     History of Changes
Other Study ID Numbers: Z161100000516237
First Submitted: November 30, 2016
First Posted: December 2, 2016
Last Update Posted: December 6, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Lin Chen, Chinese PLA General Hospital:
Gastric Cancer
Splenic Hilum Lymph Nodes Dissection
Gastrectomy

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