Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer (SNNS)
|ClinicalTrials.gov Identifier: NCT01441310|
Recruitment Status : Completed
First Posted : September 27, 2011
Last Update Posted : January 9, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Procedure: Laparoscopic sentinel node navigation surgery||Phase 2|
Prospective phase II clinical trials for sentinel node navigation surgery(SNNS) in early gastric cancer.
- ICG and 99mTc-antimony sulfur colloid (ASC) submucosal injection under intraoperative endoscopy
- Sentinel node basin identification and dissection
- Sentinel nodes picking in back table
- Frozen biopsy of sentinel nodes(hematoxylin and eosin staining and immunohistochemistry for cytokeratin)
- 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)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer|
|Study Start Date :||July 2010|
|Primary Completion Date :||August 2013|
|Study Completion Date :||August 2016|
Experimental: Laparoscopic sentinel node navigation surgery
Laparoscopic sentinel node navigation surgery
Procedure: Laparoscopic sentinel node navigation surgery
Laparoscopic SNNS using simultaneous indocyanine green (ICG) and 99mTc-antimony sulfur colloid (ASC) injections
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01441310
|Korea, Republic of|
|Seoul National University Bundang Hospital|
|Seongnam, Gyeonggi, Korea, Republic of|
|Principal Investigator:||Hyung-Ho Kim, M.D.Ph.D.||Seoul National University Bundang Hospital|