UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037095 |
|---|---|
| Receipt number | R000042269 |
| Scientific Title | Randomized controlled trial of open vs laparoscopic re-hepatectomy for recurrent liver cancer |
| Date of disclosure of the study information | 2019/06/20 |
| Last modified on | 2019/06/18 00:53:01 |
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Basic information
Public title
Randomized controlled trial of open vs laparoscopic re-hepatectomy for recurrent liver cancer
Acronym
RCT of open vs laparoscopic re-hepatectomy for recurrent liver cancer
Scientific Title
Randomized controlled trial of open vs laparoscopic re-hepatectomy for recurrent liver cancer
Scientific Title:Acronym
RCT of open vs laparoscopic re-hepatectomy for recurrent liver cancer
Region
| Japan |
Condition
Condition
Recurrent liver cancer with the indication for re-hepatectomy (hepatocellular carcinoma, combined liver cancer or metastatic liver cancer)
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aims is to access the short-term surgical outcomes open re-hepatectomy and laparoscopic re-hepatectomy for recurrent liver cancer (hepatocellular carcinoma, combined liver cancer or metastatic liver cancer)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
intraopearative blood loss
Key secondary outcomes
complication rate, operation time, period of hospital stay, surgical margin and conversion rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Laparoscopic re-hepatactomy
Interventions/Control_2
Open re-hepatectomy
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. The patients with liver cancer for re-hepatectomy
2. The patients with history of laparoscopic or open hepatectomy
3. The maximum size under 5cm and the number of tumor under 3 lesions
4. Over 20 years old
5. ECOG performance status is 0 or 1
6. Child-Pugh score is under 7
7. The functions of major organs are preserved before 28 days before registration.
8. Written informed and consent
Key exclusion criteria
1) combined resection of other organs excluded for gallbladder.
2) Serious complication of ileus, interstitial pneumonia, pulmonary fibrosis, uncontrollable diabetes, heart failure, renal failure, liver failure, active ulcer or varix, severe mental disorder and depression
3) Women who are pregnant or have the potential of pregnancy and lactating.
4) The patients enrolled for other trial with same primary endpoint.
5) The investigator judged to be unsuitable for this study.
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Hidetoshi |
| Middle name | |
| Last name | Eguchi |
Organization
Osaka University, Department of Gastroenterological Surgery
Division name
CSGO
Zip code
5650871
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3251
heguchi@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Takehiro |
| Middle name | |
| Last name | Noda |
Organization
Osaka University, Department of Gastroenterological Surgery
Division name
CSGO
Zip code
5650871
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3251
Homepage URL
tnoda@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University, Department of Gastroenterological Surgery
Institute
Department
Personal name
Funding Source
Organization
Osaka University, Department of Gastroenterological Surgery
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
IRB of Osaka University Hospital
Address
2-2 Yamadaoka, Suita, Osaka
Tel
06-6210-8289
rinri@hp-crc.med.osaka-u.ac.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 | 06 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 06 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 18 | Day |
Last modified on
| 2019 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042269
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
