3D Versus 2D Laparoscopic Total Gastrectomy With Splenic Hilum Lymph Nodes Dissection
NCT ID: NCT02984787
Last Updated: 2016-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
480 participants
INTERVENTIONAL
2017-01-31
2020-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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3D Laparoscopic total gastrectomy
Participants including in the 3D laparoscopic total gastrectomy (3D-LTG) group will undergo 3D-LTG with spleen-preserving splenic hilum lymph nodes dissection.
3D Laparoscopic total gastrectomy
When participants with advanced proximal gastric cancer are randomized in the 3D laparoscopic-assisted totalgastrectomy (3D-LTG) group, they will received 3D-LTG with spleen-preserving splenic hilum lymph nodes dissection
2D Laparoscopic total gastrectomy
Participants including in the 2D laparoscopic total gastrectomy (2D-LTG) group will undergo 2D-LTG with spleen-preserving splenic hilum lymph nodes dissection.
2D Laparoscopic total gastrectomy
When participants with advanced proximal gastric cancer are randomized in the 2D laparoscopic-assisted totalgastrectomy (2D-LTG) group, they will received 2D-LTG with spleen-preserving splenic hilum lymph nodes dissection
Interventions
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3D Laparoscopic total gastrectomy
When participants with advanced proximal gastric cancer are randomized in the 3D laparoscopic-assisted totalgastrectomy (3D-LTG) group, they will received 3D-LTG with spleen-preserving splenic hilum lymph nodes dissection
2D Laparoscopic total gastrectomy
When participants with advanced proximal gastric cancer are randomized in the 2D laparoscopic-assisted totalgastrectomy (2D-LTG) group, they will received 2D-LTG with spleen-preserving splenic hilum lymph nodes dissection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. cT2-4aN0-3M0 at preoperative evaluation according to 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
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.
18 Years
75 Years
ALL
No
Sponsors
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Chinese PLA General Hospital
OTHER
Responsible Party
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Lin Chen
Deputy Director
Principal Investigators
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Lin Chen
Role: PRINCIPAL_INVESTIGATOR
the Chinese PLA General Hospital
Locations
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Chinese PLA General Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Experiment20161201
Identifier Type: -
Identifier Source: org_study_id
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