UMIN-CTR Clinical Trial

Basic information
Public title	Short- and long-term outcome study of surgery for hilar cholangiocarcinoma in high-risk patients (multicentre study)
Acronym	High-risk hilar cholangiocarcinoma surgical survey
Scientific Title	Short- and long-term outcome study of surgery for hilar cholangiocarcinoma in high-risk patients (multicentre study)
Scientific Title:Acronym	High-risk hilar cholangiocarcinoma surgical survey
Region	Japan

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

Objectives
Narrative objectives1	To confirm the postoperative complications and prognostic information in cases of radical surgery with hepatic resection for hilar region cholangiocarcinoma and high-risk cases, and to clarify the surgical outcomes for high-risk hilar cholangiocarcinoma cases in Japan.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	5-year survival rate
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	Vascular disease: on anticoagulant medication Diabetes mellitus: taking more than one diabetes medication or using insulin (3) Do not refuse to participate in this study
Key exclusion criteria	(1) Patients with insufficient clinical data (2) Other patients who are judged by the principal investigator to be unsuitable as research subjects.
Target sample size	1200

Research contact person
Name of lead principal investigator	1st name Takehiro Middle name Last name Noji
Organization	Hokkaido university
Division name	Gastroenterological surgery II
Zip code	060-8638
Address	kita15 Nishi7, Kita-ku, Sapporo city,Japan
TEL	0117067714
Email	drnoji@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Takehiro Middle name Last name Noji
Organization	Hokkaido University
Division name	Faculty of Medicine Gastroenterological surgery II
Zip code	060-8638
Address	Kita-ku
TEL	0117067714
Homepage URL
Email	drnoji@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University
Institute
Department

Funding Source
Organization	Self-funding
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	Hokkaido University IRB
Address	Kita14 Nishi5, Kita-ku, Sapporo city, Japan
Tel	0117161161
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	2022 Year 02 Month 27 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	Enrolling by invitation
Date of protocol fixation	2022 Year 01 Month 07 Day
Date of IRB	2022 Year 01 Month 31 Day
Anticipated trial start date	2022 Year 01 Month 31 Day
Last follow-up date	2026 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

(1) Type and design of the study Multicentre observational study using existing information (2) Study items Medical information on the study subjects will be collected until December 31, 2026, and the following items will be investigated. (1) Background information: age, sex, medical history, diagnosis, treatment history, performance status 2) Hematological examination results: hemoglobin, white blood cell count, white blood cell fraction and platelet count 3) Blood chemistry test results: total protein, albumin, Na, K, serum tumor marker (CEA/CA19-9) 4) CT, MRI, ultrasound and cholangiogram results 5) Results of histopathological examination (histological type, degree of progression, lymph node metastasis) (6) Operative procedure, operative time, amount of blood loss 7) Postoperative course (presence of complications) (viii) Type and duration of postoperative treatment. (viii) Type and duration of postoperative treatment (ix) Time to recurrence, site of recurrence, prognosis of life, date of last hospital visit, cause of death

Management information
Registered date	2022 Year 01 Month 07 Day
Last modified on	2022 Year 01 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053141