Quality Control Study of Laparoscopic Sentinel Node Biopsy in Early Gastric Cancer
This study is currently recruiting participants.
Verified April 2012 by National Cancer Center, Korea
Sponsor:
National Cancer Center, Korea
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
| Tracking Information | |||||
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| First Received Date ICMJE | February 16, 2012 | ||||
| Last Updated Date | April 12, 2012 | ||||
| Start Date ICMJE | February 2012 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01544413 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Quality Control Study of Laparoscopic Sentinel Node Biopsy in Early Gastric Cancer | ||||
| Official Title ICMJE | Quality Control Study for Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy and Stomach Preserving Surgery in Early Gastric Cancer | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Early Gastric Cancer | ||||
| Intervention ICMJE | 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:
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| Study Arm (s) | 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.
Intervention: Procedure: Laparoscopic sentinel lymph node biopsy |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 160 | ||||
| Estimated Completion Date | December 2013 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Korea, Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01544413 | ||||
| Other Study ID Numbers ICMJE | SENORITA-2012 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Keun Won Ryu, National Cancer Center, Korea | ||||
| Study Sponsor ICMJE | National Cancer Center, Korea | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Center, Korea | ||||
| Verification Date | April 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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