Laparoscopic Gastrectomy for Advanced Gastric Cancer

January 6, 2017 updated by: Hyung-Ho Kim, Seoul National University Bundang Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

204

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Seongnam, Gyeonggi, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Postoperative 3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

September 25, 2011

First Submitted That Met QC Criteria

September 25, 2011

First Posted (Estimate)

September 27, 2011

Study Record Updates

Last Update Posted (Estimate)

January 9, 2017

Last Update Submitted That Met QC Criteria

January 6, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUBHGS02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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