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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
  Purpose

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 Intervention Phase
Gastric Cancer
 Procedure: Laparoscopic sentinel node navigation surgery
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 100
Study Start Date: July 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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)

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01441310

Contacts
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

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyeonggi, Korea, Republic of
Contact: Hyung-Ho Kim, M.D. Ph.D.     +82-10-3079-7095     hhkim@snubh.org    
Principal Investigator: Hyung-Ho Kim, M.D.Ph.D.            
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Hyung-Ho Kim, M.D.Ph.D. Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Hyung-Ho Kim, Principal Investigator, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01441310     History of Changes
Other Study ID Numbers: SNUBHGS01
Study First Received: September 25, 2011
Last Updated: September 26, 2011
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by Seoul National University Bundang Hospital:
Gastric cancer
Sentinel node navigation surgery
Dual method
Recurrence

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on June 18, 2013