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Laparoscopic Gastrectomy for Advanced Gastric Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2013 by Seoul National University Bundang Hospital.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Hyung-Ho Kim, Seoul National University Bundang Hospital Identifier:
First received: September 25, 2011
Last updated: December 6, 2013
Last verified: December 2013
Although laparoscopic gastrectomy (LG) is widely used for the treatment of early gastric cancer, there have been few reports of the efficacy of LAG in the management of advanced gastric cancer(AGC). The aim of this study is to evaluate the surgical outcomes and oncologic safety of laparoscopic gastrectomy for AGC.

Condition Intervention Phase
Advanced Gastric Cancer
Laparoscopic Gastrectomy
Procedure: Laparoscopic gastrectomy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

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

Primary Outcome Measures:
  • 3 year recurrence free survival [ Time Frame: Postoperative 3 year ] [ Designated as safety issue: Yes ]
    Evaluation of recurrence after regular 3 months follow-up using tumor marker, chest x-ray, endoscopy and computed tomograhy.

Estimated Enrollment: 200
Study Start Date: November 2008
Estimated Study Completion Date: July 2015
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laparoscopic gastrectomy

Laparoscopic gastrectomy procedure:

D2 lymphadenectomy & total omentectomy in case of tumor with serosa exposure under laparoscopic exploration

Procedure: Laparoscopic gastrectomy
Operative procedure: laparoscopic gastrectomy(D2 lymphadenectomy according to JGCA guideline and total omentectomy for tumor with serosa exposure)

Detailed Description:

Prospective phase II clinical trial to evaluate technical and oncological safety of LG for AGC

LG procedure for AGC:

D2 lymphadenectomy Total omentectomy for tumor with serosa exposure under laparoscopic exploration

Primary end point: 3 year disease free survival secondary end point: postoperative outcomes, morbidity and mortality, 3,5 and 7 year overall survival, Quality of life, recurrence pattern

Study duration: 7 years(enrollment: 4year, follow-up: 3year)


Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 20-80
  • informed consent
  • no other malignancies
  • cT2N0-cT3N2 according to JGCA 2nd edition
  • ASA score<3

Exclusion Criteria:

  • distant metastasis(P1 or M1) under laparoscopic exploration
  • Conglomerated N2
  • early gastric cancer in permanent pathologic report
  Contacts and Locations
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Please refer to this study by its identifier: NCT01441336

Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hyung-Ho Kim, Principal Investigator, Seoul National University Bundang Hospital Identifier: NCT01441336     History of Changes
Other Study ID Numbers: SNUBHGS02 
Study First Received: September 25, 2011
Last Updated: December 6, 2013
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases processed this record on December 06, 2016