UMIN-CTR Clinical Trial

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
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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
Email	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
Email	yuzoumeda@okayama-u.ac.jp

Sponsor
Institute	Department of Gastroenterological Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055029