Gastric Cancer
Conditions
Keywords
Gastric cancer, Sentinel node navigation surgery, Dual method, Recurrence
Brief summary
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.
Detailed description
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)
Interventions
PROCEDURELaparoscopic sentinel node navigation surgery
Laparoscopic SNNS using simultaneous indocyanine green (ICG) and 99mTc-antimony sulfur colloid (ASC) injections
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3 Year disease free survival | Postoperative 3 year | Recurrence evaluation by eddoscopy, computed tomography and Positron emission tomography if needed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sentinel node detection rate, occurrence of complication ,Qualtity of life and remnant stomach function evaluation. | postoperative 1, 3, 6, 12 month | Sentinel node detection rate and occurrence of complication of SNNS using dual method for gastric cancer were evaluated QoL questennaire and remnant stomach function were evaluated for the evaluation of patient's quality of life |
Countries
South Korea
Outcome results
None listed