UMIN-CTR Clinical Trial

Basic information
Public title	The study of left-sided portal hypertention after pancreaticoduodenectomy with combined resection of portal vein for pancreatic cancer
Acronym	The study of left-sided portal hypertention after pancreaticoduodenectomy with combined resection of portal vein
Scientific Title	The study of left-sided portal hypertention after pancreaticoduodenectomy with combined resection of portal vein for pancreatic cancer
Scientific Title:Acronym	The study of left-sided portal hypertention after pancreaticoduodenectomy with combined resection of portal vein
Region	Japan

Condition
Condition	pancreatic head cancer
Classification by specialty	Hepato-biliary-pancreatic surgery Operative medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To identify the incidence and impact of left-sided portal hypertention after PD for pancreatic cancer, which have yet to be elucidated.
Basic objectives2	Others
Basic objectives -Others	Even in the high volume centers, the method to prevent the left-sided portal hypertention is still not standardized. Therefore, we evaluate the best procedure for its prevention using multi-center questionaries.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The incidence of left-sided portal hypertention according to the various procedures. To identify it, we evaluate the incidence of gastrointestinal bleedings from the varices, platelets counts and spleen volume on POD 6 and 12 months
Key secondary outcomes	Analysis if various risk factors causing the left-sided portal hypertention after pancreaticduodenectomy

Base
Study type	Others,meta-analysis etc

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	1) Cases in which PD with PV resection were conducted. 2) Patients whose CT scan and Lab data were available on POM 6 and 12.
Key exclusion criteria	The patients of whom the criteria above mentioned were not satisfied.
Target sample size	1500

Research contact person
Name of lead principal investigator	1st name Shugo Middle name Last name Mizuno
Organization	Mie university
Division name	Hepatobiliary pancreatic and transplant surgery
Zip code	514-8507
Address	2-174 Edobashi Tsu Mie, Japan ZIP:514-8507
TEL	0592321111
Email	isaji-s@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	1st name Shugo Middle name Last name Mizuno
Organization	Mie university
Division name	Hepatobiliary pancreatic and transplant surgery
Zip code	514-8507
Address	2-174 Edobashi Tsu Mie, Japan ZIP:514-8507
TEL	0592321111
Homepage URL
Email	mizunos@clin.medic.mie-u.ac.jp

Sponsor
Institute	Hepatobiliary pancreatic and transplant surgery, Mie university
Institute
Department

Funding Source
Organization	Japanese society of hepatobiliary pancreatic surgery
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Mie University Graduate School of Medicine
Address	2-174Tsu Edobashi
Tel	0592321111
Email	katohiroyuki510719@gmail.com

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	2016 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 18 Day
Date of IRB	2016 Year 04 Month 18 Day
Anticipated trial start date	2016 Year 09 Month 10 Day
Last follow-up date	2019 Year 07 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We distributed the the first questionaries to the A ranked hospitals authorized by the Japanese society of hepatobiliary pancreatic surgery and selected the institutions in which PD with PV resection were carried out at least 10 cases from 2005.1 to 2014.12.

Management information
Registered date	2016 Year 09 Month 16 Day
Last modified on	2021 Year 03 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027720