UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Surgical results of intra-pancreatic bile duct resection for biliary malignancy
Title of the study (Brief title)	Intra-pancreatic bile duct resection
Region	Japan

Condition
Condition	Biliary malignancies
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To reveal incidence of pancreatic fistula and recurrence rate after intra pancreatic bile duct resection.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of post operative clinical relevant pancreatic fistula
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
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with biliary malignancies who underwent surgery in our department from January 2005 to December 2016.
Key exclusion criteria	Patients with pancreaticoduodenectomy
Target sample size	242

Research contact person
Name of lead principal investigator	Takehiro Noji
Organization	Hokkaido University Hospial
Division name	Gastroenterological Surgery II
Address	Kita14 Nishi5 Kita-ku Sapporo city
TEL	011-716-1161
Email	drnoji@med.hokudai.ac.jp

Public contact
Name of contact person	Takehiro Noji
Organization	Hokkaido University Hospital
Division name	Gastroenterological Surgery II
Address	Kita14Nishi5 Kita-ku Sapporo city
TEL	011-716-1161
Homepage URL
Email	drnoji@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital Gastroenterokogical Surgery II
Institute
Department

Funding Source
Organization	None: self founding
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	北海道大学病院

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 28 Day
Anticipated trial start date	2017 Year 12 Month 28 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	m January 2005 until December 2016, there were a total of 493 patients with perihilar or distal cholangiocarcinoma and gallbladder carcinoma with bile duct invasion who underwent several type of surgeries with extrahepatic bile duct resection in our department. Two hundred fifty one patients who performed pancreatoduodenectomy were excluded from this study. Finally, we evaluated 242 patients in this study.

Management information
Registered date	2017 Year 12 Month 28 Day
Last modified on	2017 Year 12 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032361