Trial Information
Quality Control Study for Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy and Stomach Preserving Surgery in Early Gastric Cancer
Inclusion Criteria:
- gastric adenocarcinoma in preoperative endoscopic biopsy
- clinical stage T1-2N0
- long diameter of tumor <4cm
- distance between tumor and pylorus or cardia >2cm
- age: 20-80
- ECOG: 1 or 0
- patients will undergo laparoscopic gastrectomy
Exclusion Criteria:
- definite criteria of endoscopic submucosal dissection (size<2cm, differentiated type,
no ulcer)
- no indication for surgery for cardiovascular, pulmonary disease
- pregancy
- drug allergy or previous abdominal surgery, radiotherpy
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Completement of performance of laparoscopic sentinel lymph node biopsy
Outcome Description:
Investigators will make out a checklist after operation for evaluating the completement of performance of laparoscopic sentinel lymph node biopsy. The checklist will be made out within 24 hours.
Outcome Time Frame:
within 24 hours after operation
Safety Issue:
No
Principal Investigator
Keun Won Ryu, Doctor
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Cancer Center, Korea
Authority:
Korea: Food and Drug Administration
Study ID:
SENORITA-2012
NCT ID:
NCT01544413
Start Date:
February 2012
Completion Date:
December 2013
Related Keywords:
- Early Gastric Cancer
- laparoscopic sentinel lymph node biopsy
- quality control study
- early gastric cancer
- Stomach Neoplasms