Status:
UNKNOWN
Laparoscopy-assisted and Open Distal Gastrectomy for Gastric Cancer in the Elderly Patients
Lead Sponsor:
Nanfang Hospital, Southern Medical University
Conditions:
Complications
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief Summary
* Laparoscopy-assisted distal gastrectomy for the treatment of early gastric cancer (EGC) has been supported by high-quality evidence, and the high-level evidence for advanced gastric cancer based on ...
Eligibility Criteria
Inclusion
- Age over 65 years
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- cT1-4a, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition
- Expected curative resection through distal subtotal gastrectomy with D2 lymphadenectomy
- Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
- ASA (American Society of Anesthesiology) score class I, II, or III
- Written informed consent
Exclusion
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
- Exclude the early gastric cancer feasible for ESD
- Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
- History of other malignant disease within past five years
- History of previous neoadjuvant chemotherapy or radiotherapy
- History of unstable angina or myocardial infarction within past six months
- History of cerebrovascular accident within past six months
- History of continuous systematic administration of corticosteroids within one month
- Requirement of simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- FEV1\<50% of predicted values
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT02246153
Start Date
September 1 2014
End Date
December 1 2017
Last Update
January 10 2017
Active Locations (1)
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1
Nanfang Hospital, Southern Medical University
Guangzhou, China, 510515