Status:
COMPLETED
Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy
Lead Sponsor:
National Cancer Center, Korea
Conditions:
Early Gastric Cancer
Eligibility:
All Genders
20-80 years
Phase:
NA
Brief Summary
Laparoscopic sentinel lymph node biopsy and stomach preserving surgery in early gastric cancer is less invasive method which can increase quality of life. For last two years, multicenter quality contr...
Detailed Description
The final analyses include the modified intention to treatment analysis (full analysis set) and Per Protocol analysis (including patients who underwent assigned surgery without agreement withdrawal). ...
Eligibility Criteria
Inclusion
- single lesion of adenocarcinoma in preoperative endoscopic biopsy
- clinical stage T1N0 in the preoperative evaluation of endoscopy and computed tomography
- tumor size: less than 3cm
- location: 2cm far from the pylorus or cardia
- aged 20 to 80
- ECOG 0 or 1
- patient who signed the agreement
- patient who is suspected to underwent laparoscopy assisted gastrectomy
Exclusion
- indication of endoscopic submucosal resection
- inoperable due to poor cardiac, pulmonary function
- pregnant
- having allergic reaction, previous upper abdominal surgery except laparoscopic cholecystectomy, previous radiation therapy to upper abdomen
- diagnosed as malignancy within 5 years except carcinoma in situ of cervix cancer and thyroid cancer
Key Trial Info
Start Date :
March 27 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2021
Estimated Enrollment :
580 Patients enrolled
Trial Details
Trial ID
NCT01804998
Start Date
March 27 2013
End Date
December 21 2021
Last Update
February 15 2022
Active Locations (7)
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1
Chonnam National University Hwasun Hospital
Hwasun, Chonnam, South Korea
2
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
3
Soonchunhyang University Bucheon Hospital
Bucheon-si, South Korea
4
Dongnam Institute of Radiological and Medical Science
Busan, South Korea