UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Concomitant portal vein resection in pancreaticoduodenectomy: Does it benefit patients with pancreatic head cancer and portal vein invasion?
Title of the study (Brief title)	Concomitant portal vein resection in pancreaticoduodenectomy
Region	Japan

Condition
Condition	Pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We aimed to identify prognostic factors for survival in patients who underwent pancreaticoduodenectomy including concomitant portal vein resection.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Survival benefit of portal vein resection
Key secondary outcomes	Morbidity, Mortality

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patiens with pancreas cancer who had done radical resection in Hokkaido Univ. Hospital department of surgery II during January 1999 to March 2009.
Key exclusion criteria	Cases with exploratory laparotomy
Target sample size	120

Research contact person
Name of lead principal investigator	Takehiro Noji
Organization	Hokkaodo University Graduate schoolof medicine
Division name	Gastroenterological Surgery II
Address	Kita 15 Nishi 7, Kita-ku, Sapporo city
TEL	011-716-1161
Email	drnoji@med.hokudai.ac.jp

Public contact
Name of contact person	Takehiro Noji
Organization	Hokkaodo University Graduate schoolof medicine
Division name	Gastroenterological Surgery II
Address	Kita 15 Nishi 7, Kita-ku, Sapporo city
TEL	011-716-1161
Homepage URL
Email	drnoji@med.hokudai.ac.jp

Sponsor
Institute	Hokkaodo University Graduate school of Medicine
Institute
Department

Funding Source
Organization	Hokkaodi University Graduate school of Medicine
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	2015 Year 04 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 01 Day
Anticipated trial start date	2015 Year 03 Month 10 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	Published
URL releasing results
Results
Other related information	112 patients were included in this retrospective study.

Management information
Registered date	2015 Year 03 Month 17 Day
Last modified on	2019 Year 02 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019457