UMIN-CTR Clinical Trial

Basic information
Public title	Role of peroral cholangioscopy in addition to computed tomography in management of indeterminate biliary stricture
Acronym	Role of peroral cholangioscopy in addition to computed tomography in management of indeterminate biliary stricture
Scientific Title	Role of peroral cholangioscopy in addition to computed tomography in management of indeterminate biliary stricture
Scientific Title:Acronym	Role of peroral cholangioscopy in addition to computed tomography in management of indeterminate biliary stricture
Region	Japan

Condition
Condition	biliary stricture
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	evaluate additional effect of peroral cholangioscope to computed tomography on diagnosis of biliary strictures and tumor spread
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Difference in agreement between the evaluation of CT and ERCP images and that with POCSadded to the final diagnosis
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) A case in which biliary stricture was diagnosed by dynamic CT and ERCP was performed at our hospital for the purpose of benign / malignant diagnosis or tumor spread 2) performing a four-phase CT without pneumobilia and biliary stent. 3) using video cholangioscope. 4) performing CT and POCS within sixty days.
Key exclusion criteria	1) pancreatic disease and tumor of duodenal papilla diagnosed without POCS. 2) patients who did not undergo radical resection or were treated before surgery for malignant disease. 3) patients who underwent follow-up of less than three years for benign disease. 4) anastomotic stricture diagnosed with medical history. 5) biliary strictures by primary hepatic cancer and metastatic tumor. 6) pancreaticobiliary maljunction without findings to suggest malignancy. 7) A case in which there was an offer to refuse participation in this study.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Naoya Middle name Last name Kato
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Gastroenterology
Zip code	260-8677
Address	Inohana 1-8-1, Chiba-City, Japan.
TEL	043-222-7171
Email	kato.naoya@chiba-u.jp

Public contact
Name of contact person	1st name Yukiko Middle name Last name Shima
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Gastroenterology
Zip code	260-8677
Address	Inohana 1-8-1, Chiba-City, Japan.
TEL	043-222-7171
Homepage URL
Email	shimako1029@gmail.com

Sponsor
Institute	Department of Gastroenterology, Graduate School of Medicine, Chiba University.
Institute
Department

Funding Source
Organization	Department of Gastroenterology, Graduate School of Medicine, Chiba University.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Chiba University Certified Review Board
Address	Inohana 1-8-1, Chiba-City, Japan.
Tel	043-222-7171
Email	igaku-rinri@office.chiba-u.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	3608
Org. issuing International ID_1	Chiba University Certified Review Board
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 11 Month 13 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	52
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	No longer recruiting
Date of protocol fixation	2019 Year 11 Month 27 Day
Date of IRB	2019 Year 12 Month 24 Day
Anticipated trial start date	2019 Year 12 Month 25 Day
Last follow-up date	2020 Year 09 Month 09 Day
Date of closure to data entry	2020 Year 09 Month 09 Day
Date trial data considered complete	2020 Year 09 Month 09 Day
Date analysis concluded

Other
Other related information	This research is retrospective cohort study.

Management information
Registered date	2020 Year 11 Month 12 Day
Last modified on	2020 Year 11 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048444