UMIN-CTR Clinical Trial

Basic information
Public title	Endoscopic ultrasound-guided choledochoduodenostomy without fistula dilation for unresectable malignant distal biliary obstruction: a phase 2 prospective trial
Acronym	CYCLONE
Scientific Title	Endoscopic ultrasound-guided choledochoduodenostomy without fistula dilation for unresectable malignant distal biliary obstruction: a phase 2 prospective trial
Scientific Title:Acronym	CYCLONE
Region	Japan

Condition
Condition	unresectable malignant distal biliary obstruction
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Efficacy and safety of EUS-CDS without fistula dilation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Technical success
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	EUS-CDS without fistula dilation
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Unresectable malignant distal biliary obstruction. 2) Indication for EUS-CDS procedure. 3) One of the following conditions (1), (2), or (3) is met. (1) Total bilirubin >1.5 mg/dL, (2) AST >100 U/L, or (3) ALT >100 U/L. 4) No parenchymal jaundice. 5) No bleeding tendency (platelets >= 50,000, prothrombin (PT) activity time >= 50%). 6) Hemoglobin level >= 8g/dL. 7) Performance status (ECOG): 0, 1, 2. 8) Age: 20 years or older. 9) Patient's written consent for participation in the study.
Key exclusion criteria	1) Judgement unsuitableness by the doctor. 2) Acute cholangitis with moderate or severe in the severity classification.
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Susumu Middle name Last name Hijioka
Organization	National Cancer Center Hospital
Division name	Department of Hepatobiliary and Pancreatic Oncology Division
Zip code	104-0045
Address	5-1-1, Tsukiji, Chuo-Ku, Tokyo, Japan
TEL	03-3542-2511
Email	shijioka@ncc.go.jp

Public contact
Name of contact person	1st name Takehiko Middle name Last name Koga
Organization	National Cancer Center Hospital
Division name	Department of Hepatobiliary and Pancreatic Oncology Division
Zip code	104-0045
Address	5-1-1, Tsukiji, Chuo-Ku, Tokyo, Japan
TEL	03-3542-2511
Homepage URL
Email	takehikoga@gmail.com

Sponsor
Institute	National Cancer Center Hospital
Institute
Department

Funding Source
Organization	National 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	National Cancer Center Hospital
Address	5-1-1, Tsukiji, Chuo-Ku, Tokyo, Japan
Tel	03-3542-2511
Email	NCC_IRBoffice@ml.res.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	2021 Year 01 Month 14 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	2021 Year 01 Month 28 Day
Date of IRB	2021 Year 01 Month 22 Day
Anticipated trial start date	2021 Year 02 Month 01 Day
Last follow-up date	2022 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 12 Month 16 Day
Last modified on	2021 Year 06 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048815

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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