Quality Control Study of Laparoscopic Sentinel Node Biopsy in Early Gastric Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by National Cancer Center, Korea.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Keun Won Ryu, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01544413
First received: February 16, 2012
Last updated: April 12, 2012
Last verified: April 2012
  Purpose

Laparoscopic sentinel lymph node biopsy and stomach preserving surgery in ealry gastric cancer is less invasive method which can increase quality of life. Multicenter phase III trial is requred to validate this method. In this study all items which are necessary for laparoscopic sentinel lymph node biopsy are identified according to checklist and evaluated the performance completement.


Condition Intervention
Early Gastric Cancer
Procedure: Laparoscopic sentinel lymph node biopsy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Quality Control Study for Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy and Stomach Preserving Surgery in Early Gastric Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • Completement of performance of laparoscopic sentinel lymph node biopsy [ Time Frame: within 24 hours after operation ] [ Designated as safety issue: No ]
    Investigators will make out a checklist after operation for evaluating the completement of performance of laparoscopic sentinel lymph node biopsy. The checklist will be made out within 24 hours.


Secondary Outcome Measures:
  • Detection rate of laparoscopic sentinel lymph node, learning curve [ Time Frame: upto 2 years ] [ Designated as safety issue: No ]
    Detection rate of laparoscopic sentinel lymph node is evaluated within 7 days after operation by pathological examination. Learning curve can be drawn after all cases' data are collected, so it takes upto 2 years.


Estimated Enrollment: 160
Study Start Date: February 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laparoscopic sentinel lymph node biopsy
This is a single armed study. After endoscopic marking using Tc99m HSA and indocyanine green fluid, Laparoscopic sentinel lymph node biopsy was performed and evalute at backtable.
Procedure: Laparoscopic sentinel lymph node biopsy
During the operation, endoscopic marking was perfomed using Tc 99m HSA and indocyanine green around tumor. Then we identify the sentinel lymph node with laparoscopic probe. Laparoscopic sentinel lymph nodes were dissedted and evaluated them at the backtable in the operating room.
Other Names:
  • Tc 99m HSA (Frosstimage)
  • indocyanine green (IC-GREEN™ (Akorn))
  • laparoscopic probe (neoprobe® GDS gamma detection system)

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • gastric adenocarcinoma in preoperative endoscopic biopsy
  • clinical stage T1-2N0
  • long diameter of tumor <4cm
  • distance between tumor and pylorus or cardia >2cm
  • age: 20-80
  • ECOG: 1 or 0
  • patients will undergo laparoscopic gastrectomy

Exclusion Criteria:

  • definite criteria of endoscopic submucosal dissection (size<2cm, differentiated type, no ulcer)
  • no indication for surgery for cardiovascular, pulmonary disease
  • pregancy
  • drug allergy or previous abdominal surgery, radiotherpy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544413

Contacts
Contact: Keun Won Ryu Ryu, Doctor 82-31-920-1628 docryu@korea.com

Locations
Korea, Republic of
Chonnam National University Hwasun Hospital Not yet recruiting
Hwasun, Chonnam, Korea, Republic of
Contact: Young Kyu Park, PhD       parkyk@jnu.ac.kr   
Sub-Investigator: Oh Jeong         
Principal Investigator: Young Kyu Park         
Sub-Investigator: Seong Yeop Ryu         
National Cancer Center, Korea Recruiting
Goyang, Gyeonggi-do, Korea, Republic of, 410-769
Contact: Keun Won Ryu, Doctor    82-31-920-1628    docryu@korea.com   
Principal Investigator: Keun Won Ryu, PhD         
Sub-Investigator: Young-Woo Kim, PhD         
Sub-Investigator: Jun Ho Lee, PhD         
Sub-Investigator: Hong Man Yoon         
Sub-Investigator: Bang Wool Eom         
Ajou University School of Medicine Not yet recruiting
Suwon, Gyeonggi-do, Korea, Republic of
Contact: Sang Uk Han, PhD       hansu@ajou.ac.kr   
Principal Investigator: Sang Uk Han, PhD         
Sub-Investigator: Hoon Hur, PhD         
Gyeongsang National University Not yet recruiting
Jinju, Gyeongsangnam-do, Korea, Republic of
Contact: Young-Joon Lee, PhD       yjlee@nongae.gsnu.ac.kr   
Principal Investigator: Young-Joon Lee, PhD         
Sub-Investigator: Sang-Ho Jeong, PhD         
Hallym University Sacred Heart Hospital Not yet recruiting
Anyang, Korea, Republic of
Contact: Ji Woong Cho       jwcho7@yahoo.co.kr   
Principal Investigator: Ji Woong Cho         
Sub-Investigator: Man Sup Lim         
Soonchunhyang University Bucheon Hospital Not yet recruiting
Bucheon, Korea, Republic of
Contact: Gyu-Seok Cho       gschogs@schbc.ac.kr   
Principal Investigator: Gyu-Seok Cho         
Sub-Investigator: Gui-Ae Jeong         
Dong-A University College of Medicine Not yet recruiting
Busan, Korea, Republic of
Contact: Min Chan Kim       mckim@donga.ac.kr   
Principal Investigator: Min Chan Kim         
Sub-Investigator: Ki Han Kim         
Dongnam Institute of Radiological and Medical Science Not yet recruiting
Busan, Korea, Republic of
Contact: Jae-Seok Min       mdoogy@hanmail.net   
Principal Investigator: Jae-Seok Min         
Keimyung University School of Medicine Not yet recruiting
Daegu, Korea, Republic of
Contact: Seung-Wan Ryu       gsman@dsmc.or.kr   
Principal Investigator: Seung-Wan Ryu         
Yonsei Univeristy College of Medicine Not yet recruiting
Seoul, Korea, Republic of
Contact: Woo Jin Hyung, PhD       wjhyung@yuhs.ac   
Sub-Investigator: Ji Yeong An, PhD         
Principal Investigator: Woo Jin Hyung         
Korea University College of Medicine Not yet recruiting
Seoul, Korea, Republic of
Contact: Sung Soo Park       kugspss@korea.ac.kr   
Principal Investigator: Sung Soo Park         
Kyung Hee University Gangdong Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Sung Il Choi, drchoi@khu.ac.kr         
Principal Investigator: Sung Il Choi         
Seoul St. Mary's Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Hae Myung Jeon       hmjeon@catholic.ac.kr   
Principal Investigator: Hae Myung Jeon         
Sub-Investigator: Kyo Young Song         
Korea University Guro Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: You Jin Jang, PhD       jyjclick@korea.ac.kr   
Principal Investigator: You Jin Jang, PhD         
Yeouido St. Mary's Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Wook Kim       kimwook@catholic.ac.kr   
Principal Investigator: Wook Kim         
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Keun Won Ryu, Doctor National Cancer Center, Korea
  More Information

No publications provided

Responsible Party: Keun Won Ryu, Principal Investigator, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01544413     History of Changes
Other Study ID Numbers: SENORITA-2012
Study First Received: February 16, 2012
Last Updated: April 12, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by National Cancer Center, Korea:
laparoscopic sentinel lymph node biopsy
quality control study
early gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on August 28, 2014