Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy and Stomach Preserving Surgery in Early Gastric Cancer
Phase 3
20 Years
80 Years
20 Years
80 Years
Open (Enrolling)
Both
Early Gastric Cancer
Both
Early Gastric Cancer
Trial Information
Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy and Stomach Preserving Surgery in Early Gastric Cancer
Inclusion Criteria:
- 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 Criteria:
- indication of endoscopic submucosal resection
- inoperable due to poor cardiac, pulmonary function
- pregnant
- having allergic reaction, previously abdominal surgery, radiation therapy
- diagnosed as malignancy within 5 years
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
3 year disease free survival
Outcome Description:
A total of enrollment period is suspected to be four years and patients will be followed up for three years. Therefore, we can complete data collection at three year later from when the last enrolled patients underwent intervention
Outcome Time Frame:
3 years after surgery
Safety Issue:
No
Authority:
Korea: Institutional Review Board
Study ID:
SENORITA 2013
NCT ID:
NCT01804998
Start Date:
March 2013
Completion Date:
March 2020
Related Keywords:
- Early Gastric Cancer
- laparoscopic sentinel lymph node biopsy
- phase 3
- early gastric cancer
- Stomach Neoplasms
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