UMIN-CTR Clinical Trial

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
Email	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
Email	uetsukik@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052785