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Laparoscopic Gastrectomy for Advanced Gastric Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hyung-Ho Kim, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01441336
First received: September 25, 2011
Last updated: January 6, 2017
Last verified: January 2017
  Purpose
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: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Laparoscopic Gastrectomy for Advanced Gastric Cancer

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 ]
    Evaluation of recurrence after regular 3 months follow-up using tumor marker, chest x-ray, endoscopy and computed tomograhy.


Enrollment: 204
Study Start Date: November 2008
Study Completion Date: July 2015
Primary Completion Date: July 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)

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01441336

Locations
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hyung-Ho Kim, Principal Investigator, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01441336     History of Changes
Other Study ID Numbers: SNUBHGS02
Study First Received: September 25, 2011
Last Updated: January 6, 2017
Individual Participant Data  
Plan to Share IPD: No

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 April 21, 2017