UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048291 |
|---|---|
| Receipt number | R000055029 |
| Scientific Title | Clinical implication and optimal extent of lymphadenectomy for intrahepatic cholangiocarcinoma: multicenter analysis of therapeutic index. |
| Date of disclosure of the study information | 2022/07/05 |
| Last modified on | 2022/07/05 19:33:16 |
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Basic information
Public title
Multicenter analysis of the clinical implication of lymphadenectomy for intrahepatic cholangiocarcinoma
Acronym
Multicenter analysis of the clinical implication of lymphadenectomy for intrahepatic cholangiocarcinoma
Scientific Title
Clinical implication and optimal extent of lymphadenectomy for intrahepatic cholangiocarcinoma: multicenter analysis of therapeutic index.
Scientific Title:Acronym
Clinical implication and optimal extent of lymphadenectomy for intrahepatic cholangiocarcinoma: multicenter analysis of therapeutic index.
Region
| Japan |
Condition
Condition
intrahepatic cholangiocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Lymph node metastases (LNM) are lethal prognostic factors in intrahepatic cholangiocarcinoma (ICC). Lymphadenectomy is crucial for accurate staging and to be hoped as possibly oncological treatment. However, the therapeutic implication and extent of lymphadenectomy have been debated. To clarify the prognostic value and optimal extent of lymphadenectomy, the therapeutic index (TI) for each lymph node was analyzed for surgical cases that had undergone lymphadenectomy in a multi-institutional database.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Assessment of lymph node metastasis and therapeutic index of lymphadenectomy
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing surgical resection with lymph node dissection for intrahepatic cholangiocarcinoma between 1 January 2000 and 31 December 2016 at Okayama University Hospital and affiliated institutions will be included.
Key exclusion criteria
none
Target sample size
280
Research contact person
Name of lead principal investigator
| 1st name | Yuzo |
| Middle name | |
| Last name | Umeda |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Gastroenterological Surgery
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, JAPAN
TEL
086-235-7257
yuzoumeda@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuzo |
| Middle name | |
| Last name | Umeda |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Gastroenterological Surgery
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, JAPAN
TEL
086-235-7257
Homepage URL
yuzoumeda@okayama-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterological Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama university medical departments clinical research review bord committee
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, JAPAN
Tel
086-235-6503
http://www.hsc.okayama-u.ac.jp/ethics/koukai/med/
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 | 07 | 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
| 2021 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Outline of research methods
To accumulate cases of resection of intrahepatic cholangiocarcinoma at a multicentre setting comprising Okayama University Hospital and affiliated facilities and to analyze the effect of lymph node dissection retrospectively.
2. Study design
Okayama University independent study, backward-looking observational study
3. Selection policy for study subjects
Selection criteria
Subjects: 280 patients who underwent surgical resection with lymph node dissection for intrahepatic cholangiocarcinoma between 1 January 2000 and 31 December 2016 at Okayama University Hospital and related institutions will be included.
Exclusion criteria: none specified.
4. Number of planned study subjects.
280 subjects in total (breakdown: 57 at Okayama University Hospital, 223 at other institutions)
5. Basis for setting the number of subjects
The number of subjects will be 280, including 57 patients who underwent surgical resection with lymph node dissection at the University between 1 January 2000 and 31 December 2016, when more than five years have passed since cancer recurred. The prognostic outcome was known, plus 223 patients who underwent resection at other institutions in the pre-survey.
Management information
Registered date
| 2022 | Year | 07 | Month | 05 | Day |
Last modified on
| 2022 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055029
