UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter retrospective study of preoperative endoscopic biliary drainage status for malignant hilar biliary obstruction
Acronym	Multicenter retrospective study of preoperative endoscopic biliary drainage status for malignant hilar biliary obstruction
Scientific Title	Multicenter retrospective study of preoperative endoscopic biliary drainage status for malignant hilar biliary obstruction
Scientific Title:Acronym	Multicenter retrospective study of preoperative endoscopic biliary drainage status for malignant hilar biliary obstruction
Region	Japan

Condition
Condition	Hilar cholangiocarcinoma, gallbladder cancer
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of preoperative endoscopic biliary drainage methods in patients with malignant hilar biliary obstruction
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Dysfunction rate of preoperative endoscopic biliary drainage tubes/stents until surgery
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) primary malignant bile duct cancer 2) main biliary stricture located within 2 cm from the hepatic hilum 3) preoperative biliary drainage until surgery
Key exclusion criteria	1) percutaneous transhepatic biliary drainage before radical surgery 2) complex endoscopic biliary drainage methods 3) preoperative chemotherapy or radiation therapy for malignant hailr biliary obstruction 4) history of gastrointestinal tract reconstruction
Target sample size	219

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	2020 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://www.karger.com/Article/Abstract/521510
Number of participants that the trial has enrolled	219
Results	The patients were 163 men and 56 women, with a mean age of 69.7 years. Endoscopic nasobiliary drainage, conventional endoscopic biliary stenting, and endoscopic biliary inside stenting were performed using the preoperative endoscopic biliary drainage (PEBD) method in 160, 31, and 28 patients, respectively. The cumulative dysfunction rates of PEBD were not significantly different among the PEBD methods (p=0.60). The adverse event rates were were not significantly different among the PEBD groups (p = 0.70).
Results date posted	2022 Year 02 Month 11 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2022 Year 01 Month 26 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 05 Month 23 Day
Date of IRB	2019 Year 05 Month 23 Day
Anticipated trial start date	2019 Year 05 Month 23 Day
Last follow-up date	2022 Year 01 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Multicenter retrospective study

Management information
Registered date	2020 Year 06 Month 01 Day
Last modified on	2022 Year 02 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046147