Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer
This trial has been completed.
|Treatment||laparoscopic sentinel node navigation surgery|
|Sponsor||Seoul National University Bundang Hospital|
|Start date||July 2010|
|End date||August 2013|
|Trial size||101 participants|
|Trial identifier||NCT01441310, SNUBHGS01|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Laparoscopic sentinel node navigation surgery
3 Year disease free survival
time frame: Postoperative 3 year
Sentinel node detection rate, occurrence of complication ,Qualtity of life and remnant stomach function evaluation.
time frame: postoperative 1, 3, 6, 12 month
Male or female participants from 20 years up to 80 years old.
- Age 20-80
- Informed consent
- No other malignancies
- cT1N0 stage gastric cancers < 4cm
- no allergic history of isotope
- Patients eligible for endoscopic submucosal dissection(ESD) with absolute indication
|Official title||Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer|
|Principal investigator||Hyung-Ho Kim, M.D.Ph.D.|
|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)|
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