UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of PD and bile duct resection for middle bile duct cancer (Is additional-PD after bile duct segmental resection sufficient to surgical treatment for middle bile duct cancer?) Japan-Korea Collaborative Research of Hepato-Biliary-Pancreatic Surgery Biliary part
Title of the study (Brief title)	Comparison of PD and bile duct resection for middle bile duct cancer (Is additional-PD after bile duct segmental resection sufficient to surgical treatment for middle bile duct cancer?) Japan-Korea Collaborative Research
Region	Japan Asia(except Japan)

Condition
Condition	Middle bile duct cancer
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare the surgical outcomes of bile duct segmental resection (BDSR) and Pancreaticoduodenectomy (PD) for middle bile duct cancer To verify whether the additional PD after BDSR to achieve negative bile duct margin have similar survival as straightforward PD.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	desease free survival
Key secondary outcomes	Overall survival R0 resection rate Morbidity rate Mortality rate Recurrence rate Site of Recurrence

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	-Middle bile duct cancer (definition of middle bile duct cancer is described above) -Resected between 2001-2010 -Clinically T1, T2, T3 (without invasion to liver parenchyma by preoperative diagnostic imaging and intraoperative macroscopic findings) in TNM 7th classification (ICD-O C24.0) (cT1/2/3 but pT4 cancer should be included) -M0 -Surgical strategies are defined as bile duct segmental resection (BDSR), pancreaticoduodenectomy including PD, PpPD and SSPPD (PD) and additional PD (AdPD).
Key exclusion criteria	-Bismuth type I hilar cholangiocarcinoma -cT4 cancer (With invasion to liver parenchyma by preoperative diagnostic imaging and intraoperative macroscopic findings) (cT1/2/3 but pT4 cancer should not be excluded) -M1 desease -Preoperative chemotherapy and/or radiation -With hepatectomy (additional hepatectomy after BDSR or PD is excluded in this study) -Patient with other cancer within 5-year
Target sample size	3600

Research contact person
Name of lead principal investigator	Michiaki Unno
Organization	Tohoku University Graduate School of Medicine
Division name	Gastroenterology
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL	022-717-7205
Email	m_unno@surg1.med.tohoku.ac.jp

Public contact
Name of contact person	Hiroki Hayashi
Organization	Tohoku University Graduate School of Medicine
Division name	Gastroenterology
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL	022-717-7205
Homepage URL
Email	hiroki@surg1.med.tohoku.ac.jp

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

Funding Source
Organization	None
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 04 Month 01 Day
Anticipated trial start date	2015 Year 06 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	Biliary part of Japan-Korea Collaborative Research of Hepato-Biliary-Pancreatic Surgery Biliary part

Management information
Registered date	2015 Year 06 Month 16 Day
Last modified on	2017 Year 12 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019949