UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017915 |
|---|---|
| Receipt number | R000020558 |
| Scientific Title | Surgical Standardization in Extent of Lymph Node Dissection for Treating Intrahepatic Cholangiocelluar Carcinoma: Complete LN dissection vs. LN sampling |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2016/06/16 10:38:33 |
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Basic information
Public title
Surgical Standardization in Extent of Lymph Node Dissection for Treating Intrahepatic Cholangiocelluar Carcinoma: Complete LN dissection vs. LN sampling
Acronym
Surgical Standardization in Extent of Lymph Node Dissection for Treating Intrahepatic Cholangiocelluar Carcinoma: Complete LN dissection vs. LN sampling
Scientific Title
Surgical Standardization in Extent of Lymph Node Dissection for Treating Intrahepatic Cholangiocelluar Carcinoma: Complete LN dissection vs. LN sampling
Scientific Title:Acronym
Surgical Standardization in Extent of Lymph Node Dissection for Treating Intrahepatic Cholangiocelluar Carcinoma: Complete LN dissection vs. LN sampling
Region
| Japan | Asia(except Japan) |
Condition
Condition
Intrahepatic cholangiocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
(1) To evaluate oncologic efficacy of LN dissection in treating IH-CCC
(2) To provide general consensus and clinical information of routine LN dissection in treating IH-CCC
(2) To provide the strong backbone to perform future randomized controlled trial
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival
Key secondary outcomes
General characteristics of the patients
-Perioperative outcomes
-Oncologic Impact of LN retrieval in resected IH-CCC
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
- Intrahepatic cholangiocarcinoma
- Not invading extrahepatic bile duct
- Not invading adjacent organ
- No combined resection
- No gallbladder cancer
- No neoadjuvant chemo +/- radiation therapy
- Potentially curative resection (R1+R0)
Key exclusion criteria
- liver cirrhosis
- No curative resection (R2)
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiaki Unno |
Organization
Tohoku Univeristy
Division name
Gastroenterological surgery
Zip code
Address
1-1 Seiryo-Machi, Aoba-ku, Sendai city
TEL
022-717-7205
m_unno@surg1.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Hayashi |
Organization
Tohoku University
Division name
Gastroenterological surgery
Zip code
Address
1-1 Seiryo-Machi, Aoba-ku, Sendai city
TEL
022-717-7205
Homepage URL
hiroki@surg1.med.tohoku.ac.jp
Sponsor or person
Institute
Japanese society of Hepato-Biliary-Pancreatic Surgery
Institute
Department
Personal name
Funding Source
Organization
Gastroenterological surgery, Tohoku University
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
Address
Tel
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
| 2015 | Year | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
the survival outcome differences is evaluate by extent of lymph node dissection
Management information
Registered date
| 2015 | Year | 06 | Month | 16 | Day |
Last modified on
| 2016 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020558
