Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy
Conditions
Early Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
laparoscopic sentinel lymph node biopsy, phase 3, early gastric cancer
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Laparoscopic Sentinel Node Biopsy Type: Procedure
Name: Laparoscopy Assisted Gastrectomy Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 20 Years
Gender: Both
Criteria: Inclusion Criteria:

- single lesion of adenocarcinoma in preoperative endoscopic biopsy

- clinical stage T1N0 in the preoperative evaluation of endoscopy and computed tomography

- tumor size: less than 3cm

- location: 2cm far from the pylorus or cardia

- aged 20 to 80

- ECOG 0 or 1

- patient who signed the agreement

- patient who is suspected to underwent laparoscopy assisted gastrectomy

Exclusion Criteria:

- indication of endoscopic submucosal resection

- inoperable due to poor cardiac, pulmonary function

- pregnant

- having allergic reaction, previously abdominal surgery, radiation therapy

- diagnosed as malignancy within 5 years
Locations
Chonnam National University Hwasun Hospital
Hwasun, Chonnam, Korea, Republic of
Status: Not yet recruiting
Contact: Young Kyu Park, PhD - 82-61-379-7644 - parkyk@jnu.ac.kr
National Cancer Center
Goyang, Gyeonggi-do, Korea, Republic of
Status: Recruiting
Contact: Keun Won Ryu, PhD - 82-31-920-1628 - docryu@korea.com
Soonchunhyang University Bucheon Hospital
Bucheon, Korea, Republic of
Status: Recruiting
Contact: Gyu-Seok Cho, PhD - 82-32-621-5248 - gschogs@schbc.ac.kr
Dongnam Institute of Radiological and Medical Science
Busan, Korea, Republic of
Status: Recruiting
Contact: Jae-Seok Min, PhD - 82-51-720-5035 - mdoogy@hanmail.net
Gyeongsang National University
Jinju, Korea, Republic of
Status: Recruiting
Contact: Young-Joon Lee, PhD - 82-55-750-8615 - yjlee@nongae.gsnu.ac.kr
Yonsei Univeristy College of Medicine
Seoul, Korea, Republic of
Status: Recruiting
Contact: Woo Jin Hyung, PhD - 82-2-2228-2129 - wjhyung@yuhs.ac
Ajou University School of Medicine
Suwon, Korea, Republic of
Status: Recruiting
Contact: Sang Uk Han, PhD - hansu@ajou.ac.kr
Start Date
March 2013
Completion Date
December 2022
Sponsors
National Cancer Center, Korea
Source
National Cancer Center, Korea
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page