UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035900
Receipt No. R000040903
Scientific Title Conversion surgery for initially unresectable biliary malignancies: A multicentre retrospective cohort study
Date of disclosure of the study information 2019/02/17
Last modified on 2019/02/17

* 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 Conversion surgery for initially unresectable biliary malignancies: A multicentre retrospective cohort study
Acronym Conversion surgery for biliary malignancy
Scientific Title Conversion surgery for initially unresectable biliary malignancies: A multicentre retrospective cohort study
Scientific Title:Acronym Conversion surgery for biliary malignancy
Region
Japan

Condition
Condition Biliary malignancy
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Feasibility of surgery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 5 year survival
Key secondary outcomes Post operative complications

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) presence of initially unresectable biliary cancer; and 2) having undergone radical surgical resection following the achievement of stable disease (SD), partial response (PR) or complete response (CR) over three months
Key exclusion criteria Data missing
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hokkaido University
Organization Faculty of Medicine
Division name Gastroenterological surgery II
Zip code
Address Kita15 Nishi7, Kita-ku, Sapporo city, Hokkaido Japan
TEL 011-716-1161
Email drnoji@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takehiro Noji
Organization Hokkaido University
Division name Faculty of Medicine, Gastroenterological surgery II
Zip code
Address Kita15 Nishi7, Kita-ku, Sapporo city, Hokkaido Japan
TEL 0117067714
Homepage URL
Email drnoji@med.hokudai.ac.jp

Sponsor
Institute Hokkaido univeristy gastroenterological surgery II
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
Address
Tel
Email

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
2019 Year 02 Month 17 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 Completed
Date of protocol fixation
2016 Year 12 Month 05 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Six of nine training institutes for highly advanced surgery, registered by the committee of Japanese Society of Hepato-Biliary-Pancreatic Surgery (in Hokkaido), are participants of the HOCS group. A multicentre survey was conducted by the HOCS group for the collection of clinical data on patients who underwent conversion surgery, from January 2005 to December 2017.

Management information
Registered date
2019 Year 02 Month 17 Day
Last modified on
2019 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040903

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.