Clinical Outcomes of Laparoscopic D1 Versus D2 Lymphadenectomy for Elderly Patients With Advanced Gastric Cancer
NCT ID: NCT03290209
Last Updated: 2020-02-05
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
PHASE2
160 participants
INTERVENTIONAL
2017-08-01
2023-08-31
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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Laparoscopic D1 Lymphadenectomy
Laparoscopic D1 Lymphadenectomy will be performed for the treatment of patients assigned to this group.
Laparoscopic D1 Lymphadenectomy
After exclusion of T4b, bulky lymph nodes, or distant metastasis case, laparoscopic D1 Lymphadenectomy will be performed in the experimental group.
Laparoscopic D2 Lymphadenectomy
Laparoscopic D2 Lymphadenectomy will be performed for the treatment of patients assigned to this group.
Laparoscopic D2 Lymphadenectomy
After exclusion of T4b, bulky lymph nodes, or distant metastasis case, laparoscopic D2 Lymphadenectomy will be performed in the comparator group.
Interventions
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Laparoscopic D1 Lymphadenectomy
After exclusion of T4b, bulky lymph nodes, or distant metastasis case, laparoscopic D1 Lymphadenectomy will be performed in the experimental group.
Laparoscopic D2 Lymphadenectomy
After exclusion of T4b, bulky lymph nodes, or distant metastasis case, laparoscopic D2 Lymphadenectomy will be performed in the comparator group.
Eligibility Criteria
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Inclusion Criteria
2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy, including gastric multiple primary carcinoma
3. cT2-4a(clinical stage tumor), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
4. expected to perform distal, total or proximal gastrectomy to obtain R0 resection sugicall results.
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
2. History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
3. History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer)
4. Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging
5. History of other malignant disease within the past 5 years
6. History of previous neoadjuvant chemotherapy or radiotherapy
7. History of unstable angina or myocardial infarction within the past 6 months
8. History of cerebrovascular accident within the past 6 months
9. History of continuous systematic administration of corticosteroids within 1 month
10. Requirement of simultaneous surgery for other disease
11. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
12. FEV1\<50% of the predicted values
75 Years
ALL
No
Sponsors
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Fujian Medical University
OTHER
Responsible Party
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Chang-Ming Huang, Prof.
Director, Head of gastric surgery, Principal Investigator, Clinical Professor
Principal Investigators
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Changming Huang, Professor
Role: PRINCIPAL_INVESTIGATOR
Fujian Medical University Union Hospital
Locations
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Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Countries
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Other Identifiers
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2017-03
Identifier Type: -
Identifier Source: org_study_id
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