NCT01441310

Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic sentinel node navigation surgery	Laparoscopic SNNS using simultaneous indocyanine green (ICG) and 99mTc-antimony sulfur colloid (ASC) injections

Timeline

• Start date: 2010-07-01
• Primary completion: 2013-08-01
• Completion: 2016-08-01
• First posted: 2011-09-27
• Last updated: 2017-01-09

Locations

1 site across 1 country: South Korea