This trial is active, not recruiting.

Condition gastric cancer
Treatment laparoscopic sentinel node navigation surgery
Phase phase 2
Sponsor Seoul National University Bundang Hospital
Start date July 2010
End date August 2013
Trial size 100 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Laparoscopic sentinel node navigation surgery
laparoscopic sentinel node navigation surgery
Laparoscopic SNNS using simultaneous indocyanine green (ICG) and 99mTc-antimony sulfur colloid (ASC) injections

Primary Outcomes

3 Year disease free survival
time frame: Postoperative 3 year

Secondary Outcomes

Sentinel node detection rate, occurrence of complication ,Qualtity of life and remnant stomach function evaluation.
time frame: postoperative 1, 3, 6, 12 month

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

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

Additional Information

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)
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Seoul National University Bundang Hospital.