UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008131 |
|---|---|
| Receipt number | R000009571 |
| Scientific Title | Randomized controlled trial of double lumen peripherally inserted central venous catheter and double lumen central venous catheter during the perioperative period of esophagectomy for esophageal cancer |
| Date of disclosure of the study information | 2012/06/09 |
| Last modified on | 2013/12/09 09:33:40 |
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Basic information
Public title
Randomized controlled trial of double lumen peripherally inserted central venous catheter and double lumen central venous catheter during the perioperative period of esophagectomy for esophageal cancer
Acronym
Randomized controlled trial of double lumen peripherally inserted central venous catheter and double lumen central venous catheter during the perioperative period of esophagectomy for esophageal cancer
Scientific Title
Randomized controlled trial of double lumen peripherally inserted central venous catheter and double lumen central venous catheter during the perioperative period of esophagectomy for esophageal cancer
Scientific Title:Acronym
Randomized controlled trial of double lumen peripherally inserted central venous catheter and double lumen central venous catheter during the perioperative period of esophagectomy for esophageal cancer
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Comparison of double lumen peripherally inserted central venous catheter and double lumen central venous catheter during the perioperative period of esophagectomy for esophageal cancer by randomized controlled trial
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Completion of the purpose of insertion of double lumen catheter from insertion of catheter through discharge from the intensive care unit
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Period: From insertion of catheter through discharge from the intensive care unit
Catheter: 4.5Fr double lumen peripherally inserted central venous catheter 60cm
Interventions/Control_2
Period: From insertion of catheter through discharge from the intensive care unit
Catheter: 16G double lumen central venous catheter 30cm
Insertion point: Subclavian vein
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Need for insertion of central venous catheter via subclavian vein before surgery for esophageal cancer
2. Aged 20 to 79 years old
3. Written informed consent for participation
Key exclusion criteria
1. Large lung bulla or severe emphysema
2. Anticoagulant or antiplatelet therapy within 2 weeks
3. A history of pulmonary embolism, deep venous thrombosis and endocarditis
4. Insertion during the operation or after the operation
5. Inadequate condition for this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyokazu Nakajima |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
2-2 Yamadaoka, Suita, 565-0871 JAPAN
TEL
06-6879-3251
knakajima@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuichi Fukuda |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
2-2 Yamadaoka, Suita, 565-0871 JAPAN
TEL
06-6879-3251
Homepage URL
s.f4911@nifty.com
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka University Graduate School of Medicine
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 09 | 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
| 2012 | Year | 06 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 09 | Day |
Last modified on
| 2013 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009571
| 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 |
