Status:
COMPLETED
Clinical Trial for Laparoscopic D2 Gastrectomy
Lead Sponsor:
National Cancer Center, Korea
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Objectives of this study was to determine whether laparoscopy-assisted distal gastrectomy (LADG) with complete D2 lymph node dissection for gastric cancer is a safe and effective surgical option. Met...
Detailed Description
Gastric cancer is the most common cancer in Korea; the overall age-standardized incidence rates of gastric cancer in Korea have been reported to be 69.6 per 100,000 among males and 26.8 per 100,000 am...
Eligibility Criteria
Inclusion
- Histologically confirmed adenocarcinoma of the stomach,
- Age between 18 and 75 years, performance status of ECOG 0-1
- Signed informed consent
- Location of the primary tumor in the antrum, angle and lower body
- No evidence of distant metastasis or invasion to adjacent organs or serosal infiltration,
- Enlarged lymph node size 2 cm or less on CT and no conglomerate nodes or regional
- Lymph node metastasis confined to perigastric nodes (N1) as shown on by CT and EUS
Exclusion
- Metastatic disease, previous history of malignancy in any organ, any co-morbidity
- Obviating major surgery, contraindication to laparoscopy such as severe cardiac disease
- Abdominal wall hernias, diaphragmatic hernias, uncorrected coagulopathies, portal hypertension, pregnancy, previous upper abdominal surgery, complicated cases requiring emergency surgery, and an accompanying surgical condition requiring surgery at the same time
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01163812
Start Date
April 1 2006
End Date
October 1 2006
Last Update
July 19 2010
Active Locations (1)
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1
National Cancer Center
Goyang, Gyeonggido, South Korea, 411-769