Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer
20 Years
80 Years
Both
Gastric Cancer
Trial Information
Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer
Prospective phase II clinical trials for sentinel node navigation surgery(SNNS) in early
gastric cancer.
Laparoscopic SNNS:
1. ICG and 99mTc-antimony sulfur colloid (ASC) submucosal injection under intraoperative
endoscopy
2. Sentinel node basin identification and dissection
3. Sentinel nodes picking in back table
4. Frozen biopsy of sentinel nodes(hematoxylin and eosin staining and immunohistochemistry
for cytokeratin)
5. If the sentinel node biopsy by frozen section is negative, limited gastrectomy will be
performed or if positive, radical D2 gastrectomy will be performed.
Sample size: 100 cases
Study duration: 5 years( 2year enrollment, 3 year follow-up)
Inclusion Criteria:
- Age 20-80
- Informed consent
- No other malignancies
- cT1N0 stage gastric cancers < 4cm
- no allergic history of isotope
Exclusion Criteria:
- Patients eligible for endoscopic submucosal dissection(ESD) with absolute indication
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
3 Year disease free survival
Outcome Description:
Recurrence evaluation by eddoscopy, computed tomography and Positron emission tomography if needed.
Outcome Time Frame:
Postoperative 3 year
Safety Issue:
Yes
Principal Investigator
Hyung-Ho Kim, M.D.Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Seoul National University Bundang Hospital
Authority:
Korea: Ministry for Health, Welfare and Family Affairs
Study ID:
SNUBHGS01
NCT ID:
NCT01441310
Start Date:
July 2010
Completion Date:
June 2015
Related Keywords:
- Gastric Cancer
- Gastric cancer
- Sentinel node navigation surgery
- Dual method
- Recurrence
- Stomach Neoplasms
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