UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004050 |
|---|---|
| Receipt number | R000004883 |
| Scientific Title | Prospective randomized clinical trial of duration of drain placement after hepatectomy |
| Date of disclosure of the study information | 2010/08/18 |
| Last modified on | 2010/08/17 00:16:37 |
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Basic information
Public title
Prospective randomized clinical trial of duration of drain placement after hepatectomy
Acronym
Prospective randomized clinical trial of duration of drain placement after hepatectomy
Scientific Title
Prospective randomized clinical trial of duration of drain placement after hepatectomy
Scientific Title:Acronym
Prospective randomized clinical trial of duration of drain placement after hepatectomy
Region
| Japan |
Condition
Condition
hepatocellular carcinoma, intrahepatic cholangiocarcinoma, metastatic liver tumor, hepatolithiasis, liver hemangioma
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Elucidation of appropriate duration of prophylactic drain placement after hepatectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Elucidation of postoperative morbidity (intra-abdominal abscess, drain infection).
Key secondary outcomes
Elucidation of re-drainage rate, postoperative hospital stay, postoperative albumin level, postoperative performance status.
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
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Removal of prophylactic drain after hepatectomy at postoperative day 2.
Interventions/Control_2
Removal of prophylactic drain after hepatectomy at postoperative day 5.
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
Performance status of ECOG is 0 or 1.
Key exclusion criteria
Reconstruction of gastrointestinal tract.
Severe renal impairment.
Active synchronous cancers.
Severe psychiatric disorder.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoji Natsugoe |
Organization
Graduate School of Medical Sciences, Kagoshima University
Division name
Surgical Oncology and Digestive Surgery
Zip code
Address
8-35-1, Sakuragaoka, Kagoshima 890-8520, Japan
TEL
+81-99-275-5361
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kurahara |
Organization
Graduate School of Medical Sciences, Kagoshima University
Division name
Surgical Oncology and Digestive Surgery
Zip code
Address
8-35-1, Sakuragaoka, Kagoshima 890-8520, Japan
TEL
+81-99-275-5361
Homepage URL
h-krhr@m3.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Graduate School of Medical Sciences, Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medical Sciences, Kagoshima University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
鹿児島大学病院（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 08 | Month | 18 | 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
| 2010 | Year | 08 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 07 | 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 | 08 | Month | 17 | Day |
Last modified on
| 2010 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004883
