UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037457
Receipt number R000042701
Scientific Title The correlation between the portal vein pressure after major hepatectomy and postoperative liver failure: a prospective observational study
Date of disclosure of the study information 2019/08/01
Last modified on 2024/01/25 16:00:34

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Basic information

Public title

The correlation between the portal vein pressure after major hepatectomy and postoperative liver failure

Acronym

The correlation between the portal vein pressure and postoperative liver failure

Scientific Title

The correlation between the portal vein pressure after major hepatectomy and postoperative liver failure: a prospective observational study

Scientific Title:Acronym

The correlation between the portal vein pressure after major hepatectomy and postoperative liver failure

Region

Japan


Condition

Condition

Perihilar cholangiocarcinoma or metastatic liver cancer without cirrhosis

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To examine the efficacy of portal vein pressure measurement before and after portal vein embolization or major hepatectomy to predict postoperative liver failure.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The correlation of the incidence of postoperative liver failure and the elevation of portal vein pressure after hepatectomy.

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

20 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Patients who are diagnosed with perihilar cholangiocarcinoma or metastic liver cancer without cirrhosis
2) Patients who undergo portal vein embolization
3) Performance status should be 0-1.
4) Patients who understand the explanation of this study

Key exclusion criteria

1) Patients with cirrhosis
2) Patients who was considered inappropriate by doctors

Target sample size

30


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 or person

Institute

The Cancer Institute Hospital Of JFCR

Institute

Department

Personal name



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



Other administrative information

Date of disclosure of the study information

2019 Year 08 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

Enrolling by invitation

Date of protocol fixation

2019 Year 07 Month 23 Day

Date of IRB

2019 Year 07 Month 23 Day

Anticipated trial start date

2019 Year 08 Month 01 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2019 Year 07 Month 23 Day

Last modified on

2024 Year 01 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042701


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name