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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008131
Receipt No. 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

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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
Email 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
Email s.f4911@nifty.com

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009571

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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