UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036603 |
|---|---|
| Receipt number | R000040517 |
| Scientific Title | The study of efficacy of preoperative diagnoasis of lymph node metastasis using endoscopic ultrasound-guided fine-needle biopsy / aspiration in patients with biliary tract cancer |
| Date of disclosure of the study information | 2019/04/25 |
| Last modified on | 2019/04/25 20:42:52 |
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Basic information
Public title
The study of efficacy of preoperative diagnoasis of lymph node metastasis using endoscopic ultrasound-guided fine-needle biopsy / aspiration in patients with biliary tract cancer
Acronym
The study of efficacy of preoperative diagnoasis of lymph node metastasis using endoscopic ultrasound-guided fine-needle biopsy / aspiration in patients with biliary tract cancer
Scientific Title
The study of efficacy of preoperative diagnoasis of lymph node metastasis using endoscopic ultrasound-guided fine-needle biopsy / aspiration in patients with biliary tract cancer
Scientific Title:Acronym
The study of efficacy of preoperative diagnoasis of lymph node metastasis using endoscopic ultrasound-guided fine-needle biopsy / aspiration in patients with biliary tract cancer
Region
| Japan |
Condition
Condition
Biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of EUS-FNA for preoperative diagnosis of lymph node metastasis in patients with biliary tract cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Diagnostic accuracy of lymph node metastasis by preoperative EUS-FNA compared with resected specimen
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Age =or >20
(2) Biliary tract cancer scheduled for radical resection
(3) Providing written informed consent
Key exclusion criteria
(1) Distant metastasis
(2) Preoperative chemotherapy or radiation therapy
(3) PT-INR =or >1.5
(4) Platelate count < 50000/m3
(5) ASA =or >3
(6) ECOG-PS=4
(7) Pregnancy
(8) Unsuitable for inclusion at the discretion of the physician
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Kuwatani |
Organization
Hokkaido University Hospital
Division name
Division of Endoscopy
Zip code
060-8648
Address
North 14, West 5, Kita-ku, Sapporo
TEL
011-716-1161
mkuwatan@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Sugiura |
Organization
Hokkaido University Faculty of Medicine and Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
060-8638
Address
North 15, West 7, Kita-ku, Sapporo
TEL
011-716-1161
Homepage URL
rsugiura-hok@umin.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Hokkaido University Hospital
Address
North 14, West 5, Kita-ku, Sapporo
Tel
011-706-7636
crjimu@huhp.hokudai.ac.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
| 2019 | Year | 04 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) Patient characteristics: age, gender, Performance status, commorbidity
2) Hematological findings: WBC, Hb, Plt, blood fraction
3) Chemistry: ALP, total billirubin, Alb, AST, ALT, gamma-GT, total protein, LDH, creatinine, BUN, amylase, lipase, CRP
4) Coagulation: PT activity(%), PT-INR
5) Tumor maker: CEA, CA19-9
6) Evaluation of the tumor: imaging (abdominal roentgenogram, CT, MRI, US, EUS)
7) Pathological findings of EUS-FNA specimen
8) Procedure characteristics of EUS-FNA (puncture site, success rate, number of puncture, with or without rapid on-site evaluation)
9) Adverse events of EUS-FNA
10) Details of surgery
11) Pathological findings of surgical specimen
Management information
Registered date
| 2019 | Year | 04 | Month | 25 | Day |
Last modified on
| 2019 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040517
