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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037095
Receipt No. 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

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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
Email 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
Email tnoda@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Osaka University, Department of Gastroenterological Surgery
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042269

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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