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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000018377
Enrollment
30
Registered
2015-07-22
Start date
2014-01-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal cancer

Interventions

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 usi

Sponsors

Yokohama City University Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Accuracy of sentinel node metastases

Secondary

MeasureTime frame
1)Sensitivity 2)Specificity 3)Positive Predictive Value(PPV) 4)Negative Predictive Value(NPV) 5)Detection rate 6)Adverse event rate

Countries

Japan

Contacts

Public ContactMitsuyoshi Ota

Yokohama City University Medical Center Gastroenerological Center

m_ota@yokohama-cu.ac.jp045-261-5656

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026