UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052737 |
|---|---|
| Receipt number | R000060171 |
| Scientific Title | Is routine lymph node dissection recommended for liver resection of intrahepatic cholangiocarcinoma? A systematic review and meta-analysis |
| Date of disclosure of the study information | 2023/11/15 |
| Last modified on | 2024/05/09 09:59:58 |
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Basic information
Public title
Is routine lymph node dissection recommended for liver resection of intrahepatic cholangiocarcinoma? A systematic review and meta-analysis
Acronym
Is routine lymph node dissection recommended for liver resection of intrahepatic cholangiocarcinoma? A systematic review and meta-analysis
Scientific Title
Is routine lymph node dissection recommended for liver resection of intrahepatic cholangiocarcinoma? A systematic review and meta-analysis
Scientific Title:Acronym
Is routine lymph node dissection recommended for liver resection of intrahepatic cholangiocarcinoma? A systematic review and meta-analysis
Region
| Japan | Asia(except Japan) | North America |
| Europe |
Condition
Condition
intrahepatic cholangiocarcinoma
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The therapeutic effect of lymph node dissection (LND) for intrahepatic cholangiocarcinoma (ICC) remains unclear. This meta-analysis aimed to elucidate the effectiveness of routine LND with liver resection for ICC.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome was the overall survival.
Key secondary outcomes
The secondary outcomes were the disease-free survival, in-hospital mortality, in-hospital morbidity, operative time, blood loss during surgery, need for blood transfusion, presence of tumor cells at the resection margins, and length of hospital stay.
Base
Study type
Others,meta-analysis etc
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
S (study type), randomized controlled trials (RCTs), and observational studies.
Studies were included if they met the following criteria: the study design was an RCT or observational study, the study discussed the OS, and the study population included patients with ICC who underwent liver resection in the presence or absence of LND.
Key exclusion criteria
Case reports, case series, and non-English-language studies were excluded.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Takamichi |
| Middle name | |
| Last name | Ishii |
Organization
Graduate School of Medicine Kyoto University
Division name
Department of Surgery
Zip code
606-8507
Address
54 Kawahara-cho Shogoin, Sakyo-ku, Kyoto, JAPAN
TEL
+81-75-751-3242
taishii@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Takamichi |
| Middle name | |
| Last name | Ishii |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Surgery
Zip code
606-8507
Address
54 Kawahara-cho Shogoin, Sakyo-ku, Kyoto
TEL
+81-75-751-3242
Homepage URL
taishii@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
None
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
N/A
Address
N/A
Tel
000
000@000
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 | 11 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/38580611/
Number of participants that the trial has enrolled
4407
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
Completed
Date of protocol fixation
| 2023 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Databases, including MEDLINE, Web of Science, and Cochrane Central Register of Controlled Trials, were searched to identify studies comparing the LND and non-LND for ICC liver resection. The primary outcome was overall survival (OS). The secondary outcomes were disease-free survival (DFS), in-hospital morbidity, blood loss, and R0 rate.
Management information
Registered date
| 2023 | Year | 11 | Month | 08 | Day |
Last modified on
| 2024 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060171
