Quality Control Study of Laparoscopic Sentinel Node Biopsy in Early Gastric Cancer
Quality Control Study for Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy and Stomach Preserving Surgery in Early Gastric Cancer
1 other identifier
interventional
112
1 country
15
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2012
Typical duration for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 16, 2012
CompletedFirst Posted
Study publicly available on registry
March 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedDecember 16, 2014
December 1, 2014
2.6 years
February 16, 2012
December 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Completement of performance of laparoscopic sentinel lymph node biopsy
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.
within 24 hours after operation
Secondary Outcomes (1)
Detection rate of laparoscopic sentinel lymph node, learning curve
upto 2 years
Study Arms (1)
Laparoscopic sentinel lymph node biopsy
EXPERIMENTALThis 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Chonnam National University Hwasun Hospital
Hwasun, Chonnam, South Korea
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, 410-769, South Korea
Ajou University School of Medicine
Suwon, Gyeonggi-do, South Korea
Gyeongsang National University
Jinju, Gyeongsangnam-do, South Korea
Korea University Guro Hospital
Seoul, Seoul, South Korea
Yonsei Univeristy College of Medicine
Seoul, Seoul, South Korea
Hallym University Sacred Heart Hospital
Anyang, South Korea
Soonchunhyang University Bucheon Hospital
Bucheon-si, South Korea
Dong-A University College of Medicine
Busan, South Korea
Dongnam Institute of Radiological and Medical Science
Busan, South Korea
Keimyung University School of Medicine
Daegu, South Korea
Korea University College of Medicine
Seoul, South Korea
Kyung Hee University Gangdong Hospital
Seoul, South Korea
Seoul St. Mary's Hospital
Seoul, South Korea
Yeouido St. Mary's Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Keun Won Ryu, Doctor
National Cancer Center, Korea
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 16, 2012
First Posted
March 5, 2012
Study Start
February 1, 2012
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
December 16, 2014
Record last verified: 2014-12