UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of concomitant replaced right hepatic arterial resection without preoperative embolization or intraoperative reconstruction during pancreaticoduodenectomy
Title of the study (Brief title)	Investigation of concomitant replaced right hepatic arterial resection without preoperative embolization or intraoperative reconstruction during pancreaticoduodenectomy
Region	Japan

Condition
Condition	Neoplasms in the pancreatic head resion
Classification by specialty	Surgery in general Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to verify the feasibility of concomitant replaced right hepatic arterial resection without preoperative embolization and intraoperative reconstruction during pancreaticoduodenectomy by analyzing perioperative findings and surgical outcomes.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidence of bilioenteric anastomotic leakage and hepatic abscess
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients underwent pancreaticoduodenectomy for tumor in the pancreatic head region at Hokkaido University Hospital Department of Gastroenterological Surgery II from January 2006 to February 2016 Patients who refuse to participate in this study
Key exclusion criteria	Patients judged inappropriate as researchers by the research director
Target sample size	323

Research contact person
Name of lead principal investigator	Satoshi Hirano
Organization	Hokkaido University Hospital
Division name	Department of Gastroenterological Surgery II
Address	West5,North 14, Kita-ku, Sapporo, 060-8648, Japan
TEL	011-716-1161
Email	satto@med.hokudai.ac.jp

Public contact
Name of contact person	Toshimichi Asano
Organization	Hokkaido University Hospital
Division name	Department of Gastroenterological Surgery II
Address	West5,North 14, Kita-ku, Sapporo, 060-8648, Japan
TEL	011-716-1161
Homepage URL
Email	toasa0616@gmail.com

Sponsor
Institute	Hokkaido University
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	2017 Year 02 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 01 Day
Anticipated trial start date	2017 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2017 Year 05 Month 30 Day
Date analysis concluded	2017 Year 05 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	Observation items Patients information: age, gender, clinical record, diagnosis Operative information: operative method, postoperative complication Blood test: AST, ALT, LDH CT findings

Management information
Registered date	2017 Year 02 Month 11 Day
Last modified on	2018 Year 02 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029989