UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Surgical Standardization in Extent of Lymph Node Dissection for Treating Intrahepatic Cholangiocelluar Carcinoma: Complete LN dissection vs. LN sampling
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Michiaki Unno
Organization	Tohoku Univeristy
Division name	Gastroenterological surgery
Address	1-1 Seiryo-Machi, Aoba-ku, Sendai city
TEL	022-717-7205
Email	m_unno@surg1.med.tohoku.ac.jp

Public contact
Name of contact person	Hiroki Hayashi
Organization	Tohoku University
Division name	Gastroenterological surgery
Address	1-1 Seiryo-Machi, Aoba-ku, Sendai city
TEL	022-717-7205
Homepage URL
Email	hiroki@surg1.med.tohoku.ac.jp

Sponsor
Institute	Japanese society of Hepato-Biliary-Pancreatic Surgery
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 05 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020558