Laparoscopic Gastrectomy for Advanced Gastric Cancer

Seoul National University

Status and phase: Completed; Phase 2

Conditions: Laparoscopic Gastrectomy; Advanced Gastric Cancer

Treatments: Procedure: Laparoscopic gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01441336

SNUBHGS02

Details and patient eligibility

About

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.

Full 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)

Enrollment: 204 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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204 participants in 1 patient group

Laparoscopic gastrectomy

Experimental group

Description:

Laparoscopic gastrectomy procedure: D2 lymphadenectomy \& total omentectomy in case of tumor with serosa exposure under laparoscopic exploration

Treatment:

Procedure: Laparoscopic gastrectomy