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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036603
Receipt No. 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

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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
Email 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
Email rsugiura-hok@umin.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040517

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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