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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003068
Receipt No. R000003720
Scientific Title Practical experience of no use or short term intraabdominal drainage in patients with hepatocellular carcinoma undergoing liver resection.
Date of disclosure of the study information 2010/02/01
Last modified on 2010/01/20

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Basic information
Public title Practical experience of no use or short term intraabdominal drainage in patients with hepatocellular carcinoma undergoing liver resection.
Acronym Practical experience of no use or short term intraabdominal drainage in patients with hepatocellular carcinoma undergoing liver resection.
Scientific Title Practical experience of no use or short term intraabdominal drainage in patients with hepatocellular carcinoma undergoing liver resection.
Scientific Title:Acronym Practical experience of no use or short term intraabdominal drainage in patients with hepatocellular carcinoma undergoing liver resection.
Region
Japan

Condition
Condition hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy and adequate duration of the intraabdominal drainage after liver resection.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rates of perctaneous drainage
Key secondary outcomes Rates of surgical site infection
Rates of remote infection
Postoperative hospital stay

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 NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Abdominal drainage after liver resection within 48 hours
Interventions/Control_2 No abdominal drainage after liver resection
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 Patients with hepatocellular carcinoma who underwent liver resection at Department of Hepato-biliary-pancreatic Surgery, Osaka City University Graduate School of Medicine
Key exclusion criteria 1)Patients who underwent reconstruction of biliary tract
2)Patients who underwent thoracotomy
3)Patients who underwent liver resection of S1, S7 or S8
4)Patients with extrahepatic lesion or vascular and/or bile duct involvement
5)Patients with liver damage B or C
6)Patients with high risk of bleeding i.e., platelets =< 50,000, bleeding time >=5 minutes, prothrombin activity => 50%
7)Patients who underwent an emergency operation
8)Patients with high risk of operation or general anesthesia i.e., cardiac, respiratory or renal failure
9)Patients without an informed consent
10)Patients who were diagnosed inadequacy for this study by a physician
Target sample size 152

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shoji Kubo
Organization Osaka City University Graduate School of Medicine
Division name Department of Hepato-biliary-pancreatic Surgery
Zip code
Address 1-4-3 Asahimachi, Abeno-ku, Osaka 545-8585, Japan
TEL 06-6645-3841
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhisa Kaneda
Organization Osaka City University Graduate School of Medicine
Division name Department of Hepato-biliary-pancreatic Surgery
Zip code
Address 1-4-3 Asahimachi, Abeno-ku, Osaka 545-8585, Japan
TEL 06-6645-3841
Homepage URL
Email

Sponsor
Institute Department of Hepato-biliary-pancreatic Surgery, Osaka City University Graduate School of Medicine
Institute
Department

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
Email

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
2010 Year 02 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 Open public recruiting
Date of protocol fixation
2009 Year 08 Month 28 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
2015 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 01 Month 20 Day
Last modified on
2010 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003720

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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