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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000037457 |
Receipt No. | 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 | 2019/07/23 |
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 |
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Condition | ||
Condition | Perihilar cholangiocarcinoma or metastatic liver cancer without cirrhosis | |
Classification by specialty |
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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 | |
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Interventions/Control_4 | |
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Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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Key exclusion criteria | 1) Patients with cirrhosis
2) Patients who was considered inappropriate by doctors |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
yu.takahashi@jfcr.or.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
Other related information | None |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.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 |