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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029259
Receipt No. R000033438
Scientific Title Reconstruction of splenic vein after pancreaticoduodenectomy with splenic vein ligation: prospective study
Date of disclosure of the study information 2017/10/01
Last modified on 2019/04/01

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Basic information
Public title Reconstruction of splenic vein after pancreaticoduodenectomy with splenic vein ligation: prospective study
Acronym Reconstruction of splenic vein after pancreaticoduodenectomy
Scientific Title Reconstruction of splenic vein after pancreaticoduodenectomy with splenic vein ligation: prospective study
Scientific Title:Acronym Reconstruction of splenic vein after pancreaticoduodenectomy
Region
Japan

Condition
Condition resectable or borderline resectable pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy of splenic vein reconstruction after pancreaticoduodenectomy with splenic vein ligation to prevent bleeding from varices that are sometimes made after this operation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The patency of reconstructed splenic vein, the development of varices and splenic hypertrophy rate.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Reconstruction of splenic vein after pancreaticoduodenectomy with splenic vein resection.
Interventions/Control_2 No reconstruction of splenic vein after pancreaticoduodenectomy with splenic vein resection.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients who undergo pancreaticoduodenectomy with splenic vein resection regardless of neoadjuvant chemo(radiation) therapy.
2) Performance status should be 0-1.
3) Patients who understand the explanation of this study.
Key exclusion criteria 1) Patients who has collaterals due to portal vein obstruction before surgery.
2) Patients who was considered inappropriate by doctors.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yu
Middle name
Last name Takahashi
Organization The Cancer Institute Hospital Of JFCR
Division name Department of Gastroenterological Surgery
Zip code 135-8550
Address 3-8-31 Ariake, Kotoku, Tokyo, Japan
TEL 03-3520-0111
Email yu.takahashi@jfcr.or.jp

Public contact
Name of contact person
1st name Yoshihiro
Middle name
Last name Ono
Organization The Cancer Institute Hospital Of JFCR
Division name Department of Gastroenterological Surgery
Zip code 135-8550
Address 3-8-31 Ariake, Kotoku, Tokyo, Japan
TEL 03-3520-0111
Homepage URL
Email yoshihiro.ono@jfcr.or.jp

Sponsor
Institute The Cancer Institute Hospital Of JFCR
Institute
Department

Funding Source
Organization The Cancer Institute Hospital Of JFCR
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization The Cancer Institute Hospital Of JFCR
Address 3-8-31 Ariake, Kotoku, Tokyo, Japan
Tel 03-3520-0111
Email yoshihiro.ono@jfcr.or.jp

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 がん研有明病院

Other administrative information
Date of disclosure of the study information
2017 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 Preinitiation
Date of protocol fixation
2017 Year 05 Month 15 Day
Date of IRB
2017 Year 10 Month 03 Day
Anticipated trial start date
2017 Year 10 Month 03 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 23 Day
Last modified on
2019 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033438

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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