Unique ID issued by UMIN | UMIN000018377 |
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Receipt number | R000021277 |
Scientific Title | Selective Sentinel Lymph Node Dissection and a One-step Nucleic Acid Amplification Assay for the Identification of Lateral Pelvic Lymph Node Metastasis in Rectal Cancer |
Date of disclosure of the study information | 2015/07/22 |
Last modified on | 2017/07/04 16:12:16 |
Selective Sentinel Lymph Node Dissection and a One-step Nucleic Acid Amplification Assay for the Identification of Lateral Pelvic Lymph Node Metastasis in Rectal Cancer
Sentinel OSNA assay of the lateral pelvic region
Selective Sentinel Lymph Node Dissection and a One-step Nucleic Acid Amplification Assay for the Identification of Lateral Pelvic Lymph Node Metastasis in Rectal Cancer
Sentinel OSNA assay of the lateral pelvic region
Japan |
Rectal cancer
Gastrointestinal surgery |
Malignancy
NO
The aim of this study is to evaluate the feasibility of sentinel node metastases of lateral pelvic region in locally advanced rectal cancer using the one-step nucleic acid amplification assay.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Accuracy of sentinel node metastases
1)Sensitivity
2)Specificity
3)Positive Predictive Value(PPV)
4)Negative Predictive Value(NPV)
5)Detection rate
6)Adverse event rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Diagnosis
Medicine |
After Total Mesorectal excision(TME) for primary lesion, lateral pelvic node dissection was performed and picked up lymph nodes around inferior vesical artery as sentinel basin which were examined using the one-step nucleic acid amplification assay.
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1) Histologically proven as adenocarcinomas
2) clinical stage II or III
3) 1) Tumor located below the peritoneum.
4) Aged between 20 and 80 years old
5) ECOG Performance status of 0 or 1
6) no severe comobidity or organ disorder
7) willing to provide written informed consent
1) History of severe drug hypersensitivity
2) history of another malignancy within 5 years
3) Severe concurrent disease such as poorly controlled hypertension, poorly controlled diabetes, interstitial pneumonia or pulmonary fibrosis, severe chronic pulmonary emphysema, heart failure, renal failure, hepatic failure.
4) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males who are currently attempting to produce a pregnancy
5) Physician concludes that the patient's participation in this trial is inappropriate
30
1st name | |
Middle name | |
Last name | Mitsuyoshi Ota |
Yokohama City University Medical Center
Gastroenterological surgery
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
045-261-5656
m_ota@yokohama-cu.ac.jp
1st name | |
Middle name | |
Last name | Mitsuyoshi Ota |
Yokohama City University Medical Center
Gastroenerological Center
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japa
045-261-5656
m_ota@yokohama-cu.ac.jp
Yokohama City University Medical Center
None
Self funding
NO
2015 | Year | 07 | Month | 22 | Day |
Unpublished
No longer recruiting
2013 | Year | 11 | Month | 01 | Day |
2014 | Year | 01 | Month | 01 | Day |
2015 | Year | 07 | Month | 22 | Day |
2017 | Year | 07 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021277
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