UMIN-CTR Clinical Trial

Basic information
Public title	The efficiency of hepatopancreatoduodenectomy for biliary malignancy
Acronym	The efficiency of hepatopancreatoduodenectomy for biliary malignancy
Scientific Title	The efficiency of hepatopancreatoduodenectomy for biliary malignancy
Scientific Title:Acronym	The efficiency of hepatopancreatoduodenectomy 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	To determine the appropriate indication for HPD in patients with advanced biliary tract cancer by examining the relationship between 5-year survival and clinical information.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	5-year survival rate
Key secondary outcomes	(1) Perioperative outcomes (complications and mortality) 2) Association between clinical factors and long-term prognosis

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) Those who have undergone HPD 2) Those who 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	61

Research contact person
Name of lead principal investigator	1st name Takehiro Middle name Last name Noji
Organization	Hokkaido University Hosp
Division name	Gastroenterological surgery II
Zip code	060-8638
Address	Kita14 Nishi5, 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 Hospital
Division name	Gastroenterological surgery II
Zip code	060-8638
Address	Kita14 Nishi5, Kita-ku, Sapporo city
TEL	0117067714
Homepage URL
Email	drnoji@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hosp
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	IRB Hokkaido University Hospital
Address	Kita14 Nishi5, Kita-ku, Sapporo city, Hokkaido Japan
Tel	011-716-1161
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 01 Month 05 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 05 Day
Date of IRB	2022 Year 01 Month 31 Day
Anticipated trial start date	2022 Year 01 Month 05 Day
Last follow-up date	2026 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

We will collect medical information on the research subjects up to 31 August 2026 and investigate the following items 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 05 Day
Last modified on	2022 Year 01 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053112

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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