Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Keun Won Ryu, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01544413
First received: February 16, 2012
Last updated: December 14, 2014
Last verified: December 2014

February 16, 2012
December 14, 2014
February 2012
September 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01544413 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Early Gastric Cancer
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)
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
112
September 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01544413
SENORITA-2012
Yes
Keun Won Ryu, National Cancer Center, Korea
National Cancer Center, Korea
Not Provided
Principal Investigator: Keun Won Ryu, Doctor National Cancer Center, Korea
National Cancer Center, Korea
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP