UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046274 |
|---|---|
| Receipt number | R000052785 |
| Scientific Title | Usefulness of 22G needle in endoscopic ultrasound-guided biliary drainage (EUS-BD). |
| Date of disclosure of the study information | 2021/12/06 |
| Last modified on | 2021/12/03 20:47:56 |
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Basic information
Public title
Usefulness of 22G needle in endoscopic ultrasound-guided biliary drainage (EUS-BD).
Acronym
Usefulness of 22G needle in endoscopic ultrasound-guided biliary drainage (EUS-BD).
Scientific Title
Usefulness of 22G needle in endoscopic ultrasound-guided biliary drainage (EUS-BD).
Scientific Title:Acronym
Usefulness of 22G needle in endoscopic ultrasound-guided biliary drainage (EUS-BD).
Region
| Japan |
Condition
Condition
Malignant biliary obstruction
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will demonstrate the safety and efficacy of EUS-BD using a 22G puncture needle and 0.018inch guidewire compared to EUS-BD using a conventional 19G puncture needle.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Accuracy between the target angle and the actual puncture angle during the initial bile duct puncture
Key secondary outcomes
technical sucsess, stenting success on first puncture, first puncture success within tolerance (2 degrees), number of punctures required, procedure time, clinical response rate, duration of stent function maintenance, incidents, overall survival (up to 1 year)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Adopt 22G as the puncture needle for EUS-BD
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
atients who can be diagnosed as malignant biliary obstruction by imaging and pathology, and who are expected to have difficulty in trans-papillary drainage by ERCP for any of the following reasons, and who are eligible for EUS-BD and have obtained written consent
1) Gastrointestinal invasion is suspected on imaging, and it is difficult or expected to be difficult to reach the main papilla endoscopically.
2) Patients with postoperative reconstructed intestine, and difficulty in reaching the main papilla by lateral viewing duodenoscope is expected.
3) Unsuccessful drainage by ERCP
Key exclusion criteria
Less than 20 years old
Intrahepatic bile duct diameter less than 3 mm
EUS-BD puncture line cannot avoid metastatic liver tumor
Large amount of ascites
Poorly controlled infections
Severe drug allergy.
Pregnant or potentially pregnant and lactating women
Severe mental disorder
Patients who are judged by the principal investigator or sub-investigator to be unsuitable for the safe conduct of this study.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Ishikawa |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
466-8550
Address
65 Tsuruma-cho, Showa-ku, Nagoya 466-8550, Japan.
TEL
052-744-2602
ishitaku@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Uetsuki |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
466-8550
Address
65 Tsuruma-cho, Showa-ku, Nagoya 466-8550, Japan.
TEL
052-744-2602
Homepage URL
uetsukik@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
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
Nagoya University Graduate School of Medicine Department of Gastroenterology and Hepatology
Address
65 Tsuruma-cho, Showa-ku, Nagoya 466-8550, Japan.
Tel
052-744-2602
uetsukik@med.nagoya-u.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
| 2021 | Year | 12 | Month | 06 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 12 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 03 | Day |
Last modified on
| 2021 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052785
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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