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Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy

NCT01804998 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 580

Last updated 2022-02-15

No results posted yet for this study

Summary

Laparoscopic sentinel lymph node biopsy and stomach preserving surgery in early gastric cancer is less invasive method which can increase quality of life. For last two years, multicenter quality control study (Phase II) has been performed in Korea and tolerable results were observed. Based on these results, multicenter phase III trial is required to validate the clinical role of laparoscopic sentinel lymph node biopsy.

Conditions

  • Early Gastric Cancer

Interventions

PROCEDURE

Laparoscopic Sentinel Node Biopsy

Laparoscopic Sentinel Node Biopsy or Stomach Preserving Surgery could be performed in the experimental arm.

PROCEDURE

Laparoscopy Assisted Gastrectomy

In the control arm, laparoscopy assisted gastrectomy with lymph node dissection (D1+ or more) will be performed.

Sponsors & Collaborators

  • National Cancer Center, Korea

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-27
Primary Completion
2020-01-15
Completion
2021-12-21

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01804998 on ClinicalTrials.gov