UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053125 |
|---|---|
| Receipt number | R000060625 |
| Scientific Title | Diagnostic ability of EUS-TA for para-aortic lymph node in resectable pancreatobiliary tumor: single-center prospective observational study |
| Date of disclosure of the study information | 2023/12/16 |
| Last modified on | 2023/12/16 01:43:12 |
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Basic information
Public title
Diagnostic ability of EUS-TA for para-aortic lymph node in resectable pancreatobiliary tumor: single-center prospective observational study
Acronym
PALN Study
Scientific Title
Diagnostic ability of EUS-TA for para-aortic lymph node in resectable pancreatobiliary tumor: single-center prospective observational study
Scientific Title:Acronym
PALN Study
Region
| Japan |
Condition
Condition
resectable pancreatobiliary tumor
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the utility and safety of endoscopic ultrasound tissue acquisition (EUS-TA) for para-aortic lymph nodes (PALN) in resectable pancreatobiliary tumor.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Diagnostic ability of EUS-TA in puncture cases (sensitivity, specificity, positive predictive value, negative predictive value, and accuracy)
Comparison of accuracy between contrast-enhanced CT and EUS-TA
Key secondary outcomes
Technical success rate
Comparison of diagnostic ability including difficult puncture cases
Diagnostic ability of puncture cases in surgical cases
Proportion of patients for whom EUS-TA contributed to treatment decisions
Comparison of diagnostic ability of EUS findings
Adverse event
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Other imaging studies, including contrast-enhanced CT, performed within 28 days prior to the date of study.
Resectable pancreatobiliary tumor by contrast-enhanced CT diagnosis.
Age: 18 years or older.
PS(ECOG):0,1,2.
If the patient is taking antithrombotic medication, it can be discontinued according to the criteria.
No bleeding tendency.
No gastrointestinal stricture on imaging studies.
No massive ascites extending from the liver to the pelvis.
Written consent for participation in the study has been obtained from the patient.
Key exclusion criteria
Patients with active double cancer.
Patients deemed by the physician to be ineligible for enrollment in this study.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Takuji |
| Middle name | |
| Last name | Okusaka |
Organization
Natioinal cancer center hospital
Division name
Department of hepatobiliary and pancreatic oncology
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
tokusaka@ncc.go.jp
Public contact
Name of contact person
| 1st name | Hidenobu |
| Middle name | |
| Last name | Hara |
Organization
Natioinal cancer center hospital
Division name
Department of hepatobiliary and pancreatic oncology
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
hihar@ncc.go.jp
Sponsor or person
Institute
Natioinal cancer center hospital
Institute
Department
Personal name
Funding Source
Organization
Natioinal cancer center hospital
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Natioinal cancer center hospital
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
Tel
03-3542-2511
irst@ncc.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Single-center prospective observational study
Management information
Registered date
| 2023 | Year | 12 | Month | 16 | Day |
Last modified on
| 2023 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060625
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
