UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052809 |
|---|---|
| Receipt number | R000060268 |
| Scientific Title | Short and long-term surgical result for perihilar cholangiocarcinoma (major hepatectomy) after chemotherapy (Multicenter Study) |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2023/11/16 00:30:36 |
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Basic information
Public title
Short and long-term surgical result for perihilar cholangiocarcinoma (major hepatectomy) after chemotherapy
(Multicenter Study)
Acronym
Hx for PHCC after CTx
Scientific Title
Short and long-term surgical result for perihilar cholangiocarcinoma (major hepatectomy) after chemotherapy
(Multicenter Study)
Scientific Title:Acronym
Hx for PHCC after CTx
Region
| Japan |
Condition
Condition
Perihilar cholangiocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify on postoperative complications and prognosis of patients who underwent hepatectomy after anti-tumor therapy for perihilar cholangiocarcinoma, And to define the short- and long-term outcomes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Post operative morbidity and mortality
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) Perihilar cholangiocarcinoma patients with hepatectomy
2) Patients who underwent chemotherapy one month or more
3) Not applicant on exclusion criteria
4) Agree with research
Key exclusion criteria
1) lacking clinical data
2) Other reasons
3) Disagree
Target sample size
695
Research contact person
Name of lead principal investigator
| 1st name | Takehiro |
| Middle name | |
| Last name | Noji |
Organization
Hokkaido University Faculty of mediine
Division name
Faculty of Medicine Gastroenterological surgery II
Zip code
060-8638
Address
Kita15 Nishi 7, Kita-ku, Sapporo city
TEL
0117067714
drnoji@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | TAKEHIRO |
| Middle name | |
| Last name | Noji |
Organization
Hokkaido University Faculty of Medicine
Division name
Gastroenterological surgery II
Zip code
060-8638
Address
Kita15 Nishi7, Kita-ku, Sapporo city,
TEL
0117067714
Homepage URL
drnoji@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
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
Tel
0117161161
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
| 2023 | Year | 12 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | 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 study
Multicenter observational study using existing information
(2) Survey items
Medical information on the study subjects (both groups) will be collected until December 31, 2025, and the following items will be investigated.
(1) Background information: age, gender, medical history, diagnosis, treatment history, and performance status
(2) Reason, method, drug type, and duration of anti-tumor therapy.
Hematological test results immediately before and after surgery: hemoglobin, white blood cell count, white blood cell fraction and platelet count.
(iv) Hematological and biochemical test results immediately before and after surgery: total protein, albumin, Na, K, serum tumor markers (CEA/CA19-9)
(iv) CT, MRI, ultrasound, cholangiographic imaging test results
(v) Results of histopathological examination (histological type, degree of progression, lymph node metastasis)
(vi) Technique, operation time, and amount of blood loss
7) Postoperative course (presence or absence of complications)
(viii) Type and duration of postoperative treatment (ix) Period until recurrence and site of recurrence
(9) Period until recurrence, site of recurrence, life prognosis, date of last hospital visit, cause of death
Management information
Registered date
| 2023 | Year | 11 | Month | 16 | Day |
Last modified on
| 2023 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060268
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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