Quality Control Study of Laparoscopic Sentinel Node Biopsy in Early Gastric Cancer
- Conditions
- Early Gastric Cancer
- Interventions
- Procedure: Laparoscopic sentinel lymph node biopsy
- Registration Number
- NCT01544413
- Lead Sponsor
- National Cancer Center, Korea
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 112
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Laparoscopic sentinel lymph node biopsy 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.
- Primary Outcome Measures
Name Time Method Completement of performance of laparoscopic sentinel lymph node biopsy within 24 hours after operation 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
Name Time Method Detection rate of laparoscopic sentinel lymph node, learning curve upto 2 years 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.
Trial Locations
- Locations (15)
Ajou University School of Medicine
🇰🇷Suwon, Gyeonggi-do, Korea, Republic of
Gyeongsang National University
🇰🇷Jinju, Gyeongsangnam-do, Korea, Republic of
National Cancer Center, Korea
🇰🇷Goyang, Gyeonggi-do, Korea, Republic of
Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Kyung Hee University Gangdong Hospital
🇰🇷Seoul, Korea, Republic of
Yeouido St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Anyang, Korea, Republic of
Dong-A University College of Medicine
🇰🇷Busan, Korea, Republic of
Dongnam Institute of Radiological and Medical Science
🇰🇷Busan, Korea, Republic of
Soonchunhyang University Bucheon Hospital
🇰🇷Bucheon, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷Hwasun, Chonnam, Korea, Republic of
Keimyung University School of Medicine
🇰🇷Daegu, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Yonsei Univeristy College of Medicine
🇰🇷Seoul, Korea, Republic of
Korea University College of Medicine
🇰🇷Seoul, Korea, Republic of