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.
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: August 2013
Prospective phase II clinical trials for sentinel node navigation surgery(SNNS) in early gastric cancer.
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)
- Procedure: Laparoscopic sentinel node navigation surgery
- Laparoscopic SNNS using simultaneous indocyanine green (ICG) and 99mTc-antimony sulfur colloid (ASC) injections
Arms, Groups and Cohorts
- Experimental: Laparoscopic sentinel node navigation surgery
- Laparoscopic sentinel node navigation surgery
Clinical Trial Outcome Measures
- 3 Year disease free survival
- Time Frame: Postoperative 3 year
- Recurrence evaluation by eddoscopy, computed tomography and Positron emission tomography if needed.
- Sentinel node detection rate, occurrence of complication ,Qualtity of life and remnant stomach function evaluation.
- Time Frame: 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
Participating in This Clinical Trial
- 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
Gender Eligibility: All
Minimum Age: 20 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Seoul National University Bundang Hospital
- Provider of Information About this Clinical Study
- Principal Investigator: Hyung-Ho Kim, Principal Investigator – Seoul National University Bundang Hospital
- Overall Official(s)
- Hyung-Ho Kim, M.D.Ph.D., Principal Investigator, Seoul National University Bundang Hospital
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.