UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007339 |
|---|---|
| Receipt number | R000007729 |
| Scientific Title | Parital clamping of infrahepatic inferior vena cava for reduction of blood loss during hepatectomy |
| Date of disclosure of the study information | 2012/02/20 |
| Last modified on | 2016/02/23 16:21:19 |
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Basic information
Public title
Parital clamping of infrahepatic inferior vena cava for reduction of blood loss during hepatectomy
Acronym
IVC partial-clamp study
Scientific Title
Parital clamping of infrahepatic inferior vena cava for reduction of blood loss during hepatectomy
Scientific Title:Acronym
IVC partial-clamp study
Region
| Japan |
Condition
Condition
liver cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of infrahepatic inferior vena cava partial clamping for reducing blood loss during hepatectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Blood loss during surgery
Key secondary outcomes
Postoperative complications, change of circulating blood volume, blood loss during hepatic parenchimal resection, operating time
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Partial clamping of infrahepatic inferior vena cava
Interventions/Control_2
Conventional method
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 with performance status 0-2.
2) Patients with Child-Pugh grade A.
3) Patients with well maintained bone marrow and renal functions.
a) White blood cell count: 3000-12000/mm3
b) Platelet count:>=70000/mm3
c) Hemoglobin:>=10.0g/dL
d) Serum creatinine:=<1.5mg/dL
4) Central venous pressure is >=5mmHg before hepatic parenchyma resection.
5) Patients who gave written informed consent prior to the study.
Key exclusion criteria
1) Patients underwent upper abdominal surgery formerly.
2) Patients need vascular reconstruction.
3) Patients with severe cardiac dysfunction (NYHA classificaion grade III or more) or atrial fibrillation or tricuspid regurgitation.
4) Patients with deep vein thrombosis.
5) Patients with severe COPD.
6) Patients underewnt artificial dialysis.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ueno Masaki |
Organization
Wakayama medical university
Division name
Sencond department of sugery
Zip code
Address
811-1 Kimidera, Wakayama City
TEL
073-447-2300
ma@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ueno Masaki |
Organization
Wakayama medical university
Division name
Sencond department of sugery
Zip code
Address
811-1 Kimidera, Wakayama City
TEL
073-447-2300
Homepage URL
ma@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama medical university
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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
和歌山県立医科大学
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 20 | 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
| 2011 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 20 | Day |
Last modified on
| 2016 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007729
