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Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer (SNNS)

This study is currently recruiting participants.
Verified September 2011 by Seoul National University Bundang Hospital
Sponsor:
Information provided by (Responsible Party):
Hyung-Ho Kim, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01441310
First received: September 25, 2011
Last updated: September 26, 2011
Last verified: September 2011
History of Changes

September 25, 2011
September 26, 2011
July 2010
June 2012   (final data collection date for primary outcome measure)
3 Year disease free survival [ Time Frame: Postoperative 3 year ] [ Designated as safety issue: Yes ]
Recurrence evaluation by eddoscopy, computed tomography and Positron emission tomography if needed.
Same as current
Complete list of historical versions of study NCT01441310 on ClinicalTrials.gov Archive Site
Sentinel node detection rate, occurrence of complication [ Time Frame: postoperative 3 month ] [ Designated as safety issue: Yes ]
Sentinel node detection rate and occurrence of complication of SNNS using dual method for gastric cancer were evaluated
Same as current
Not Provided
Not Provided
 
Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer
Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer

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.

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)
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastric Cancer
Procedure: Laparoscopic sentinel node navigation surgery
Laparoscopic SNNS using simultaneous indocyanine green (ICG) and 99mTc-antimony sulfur colloid (ASC) injections
Experimental: Laparoscopic sentinel node navigation surgery
Laparoscopic sentinel node navigation surgery
Intervention: Procedure: Laparoscopic sentinel node navigation surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
June 2015
June 2012   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
Contact: Hyung-Ho Kim, M.D. Ph.D. +82-31-787-7095 hhkim@snubh.org
Contact: Ju-Hee Lee, M.D. +82-31-787-6158 89205@snubh.org
Korea, Republic of
 
NCT01441310
SNUBHGS01
Yes
Hyung-Ho Kim, Seoul National University Bundang Hospital
Seoul National University Bundang Hospital
Not Provided
Principal Investigator: Hyung-Ho Kim, M.D.Ph.D. Seoul National University Bundang Hospital
Seoul National University Bundang Hospital
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP