UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047499 |
|---|---|
| Receipt number | R000054161 |
| Scientific Title | A multicenter study of the efficacy of different preoperative drainage methods and their impact on surgery for hilar cholangiocarcinoma using real clinical data. |
| Date of disclosure of the study information | 2022/04/18 |
| Last modified on | 2023/04/17 18:59:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A multicenter study of the efficacy of different preoperative drainage methods and their impact on surgery for hilar cholangiocarcinoma using real clinical data.
Acronym
POD study
Scientific Title
A multicenter study of the efficacy of different preoperative drainage methods and their impact on surgery for hilar cholangiocarcinoma using real clinical data.
Scientific Title:Acronym
POD study
Region
| Japan |
Condition
Condition
Hilar cholangiocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The goal is to clarify the consensus on preoperative biliary drainage for cholangiocarcinoma of the hilar region, as well as to establish the indications and methods of preoperative biliary drainage.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of cholangitis and stent obstruction by preoperative biliary drainage method
Key secondary outcomes
Operative blood loss, R0 operative rate, incidence of infectious complications, biliary fistula, pancreatic fistula, etc., 90-day mortality rate.
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
Patients with hilar cholangiocarcinoma who underwent surgical radical surgery with preoperative biliary drainage from January 2017 to December 2020 at a Japanese Biliary Society-approved teaching facility.
1. patients who do not refuse to participate in the study of their own free will or that of their family members
2. patients who are 20 years of age or older at the time of examination and treatment
Key exclusion criteria
1. patients who refuse to participate in the research by themselves or their family members
2. Other patients deemed inappropriate by the principal investigator or principal study investigator
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yoshiki |
| Middle name | |
| Last name | Hirooka |
Organization
Fujita Health University
Division name
Department of Gastroenterology and Hepatology
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-Cho, Toyoake, Aichi
TEL
+81562932324
yoshiki.hirooka@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Senju |
| Middle name | |
| Last name | Hashimoto |
Organization
Fujita Health University
Division name
Department of Gastroenterology and Hepatology
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-Cho, Toyoake, Aichi
TEL
+81562932324
Homepage URL
hsenju@fujita-hu.ac.jp
Sponsor or person
Institute
Japan Biliary Association
Institute
Department
Personal name
Funding Source
Organization
Japan Biliary Association
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
Fujita Health University
Address
1-98, Dengakugakubo, Kutsukake-Cho, Toyoake, Aichi
Tel
+81562932865
f-irb@fujita-hu.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
| 2022 | Year | 04 | Month | 18 | 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
500
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
| 2022 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 04 | Month | 15 | Day |
Last modified on
| 2023 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054161
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
