Laparoscopic Gastrectomy for Advanced Gastric Cancer

Phase 2

Completed

• Conditions: Laparoscopic Gastrectomy; Advanced Gastric Cancer

• Registration Number: NCT01441336
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2008-11
• Study First Submitted: 2011-09-25
• Study First Submitted QC: 2011-09-25
• Study First Posted: 2011-09-27
• Primary Completion: 2012-07
• Study Completion: 2015-07
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-06
• Last Update Posted: 2017-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
3 year recurrence free survival	Postoperative 3 year	Evaluation of recurrence after regular 3 months follow-up using tumor marker, chest x-ray, endoscopy and computed tomograhy.

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of