UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040605 |
|---|---|
| Receipt number | R000046147 |
| Scientific Title | Multicenter retrospective study of preoperative endoscopic biliary drainage status for malignant hilar biliary obstruction |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2022/02/11 09:59:36 |
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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
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
rsugiura-hok@umin.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046147
