Gastric Cancer Clinical Trial
Official title:
Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer
There are few reports on a dual dye and isotope approach using laparoscopy in gastric cancer
sentinel node mapping.
The aim of this study was to evaluate the feasibility of laparoscopic limited gastrectomy
with sentinel basin(SB) dissection for gastric cancer using simultaneous indocyanine green
(ICG) and 99mTc-antimony sulfur colloid (ASC) injections.
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)
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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