Status:
UNKNOWN
Clinical Outcomes of Laparoscopic D1 Versus D2 Lymphadenectomy for Elderly Patients With Advanced Gastric Cancer
Lead Sponsor:
Fujian Medical University
Conditions:
Stomach Neoplasm
Eligibility:
All Genders
75+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to explore the clinical outcomes of laparoscopic D1 lymphadenectomy for elderly patients with advanced gastric adenocarcinoma（cT2-4a, N-/+, M0）
Detailed Description
Gastrectomy with D2 lymphadenectomy is considered the gold standard treatment for advanced gastric cancer. However, some studies show that age or comorbidities is the relevant predictor of postoperati...
Eligibility Criteria
Inclusion
- Age over or equal to 75 years
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy, including gastric multiple primary carcinoma
- cT2-4a(clinical stage tumor), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
- expected to perform distal, total or proximal gastrectomy to obtain R0 resection sugicall results.
- Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
- ASA (American Society of Anesthesiology) class I to III
- Written informed consent
Exclusion
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer)
- Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging
- History of other malignant disease within the past 5 years
- History of previous neoadjuvant chemotherapy or radiotherapy
- History of unstable angina or myocardial infarction within the past 6 months
- History of cerebrovascular accident within the past 6 months
- History of continuous systematic administration of corticosteroids within 1 month
- Requirement of simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- FEV1\<50% of the predicted values
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT03290209
Start Date
August 1 2017
End Date
August 1 2023
Last Update
February 5 2020
Active Locations (1)
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1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350000