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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024987
Receipt No. R000028751
Scientific Title Phase II clinical trial of pleurodesis with a 50% glucose solution for persistent air leak after pulmonary resection
Date of disclosure of the study information 2016/11/24
Last modified on 2017/05/26

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Basic information
Public title Phase II clinical trial of pleurodesis with a 50% glucose solution for persistent air leak after pulmonary resection
Acronym Phase II clinical trial of pleurodesis with a 50% glucose solution for persistent air leak after pulmonary resection
Scientific Title Phase II clinical trial of pleurodesis with a 50% glucose solution for persistent air leak after pulmonary resection
Scientific Title:Acronym Phase II clinical trial of pleurodesis with a 50% glucose solution for persistent air leak after pulmonary resection
Region
Japan

Condition
Condition Postoperative persistent air leak or postoperative pneumothorax after pulmonary resection
Classification by specialty
Chest surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Treatment for postoperative persistent air leak or postoperative pneumothorax is drainage, pleudolesis or operation. In Japan OK-432 has been used as pleurodesis routinely, however anaphylaxis and acute exacerbation of interstitial pneumonia has been reported as the adverse events. Otherwise the indication for the pleurodesis with OK-432 is for malignant pleural effusion. The drug price is about 7,000 yen and so expensive. Therefore safe and low-cost drug is expected. Pleurodesis with a 50% glucose solution has been reported for several years. The treatment cause hyperglycemia, however it has been reported as the safe and low-cost treatment. On the other hand there is no prospective study about the effect and adverse events and we planed this study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Rate of stopping air leakage after pleurodesis with a 50% glucose solution
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 50% glucose solution group
Interventions/Control_2
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 Postoperative persistent air leak or postoperative pneumothorax after pulmonary resection
Key exclusion criteria 1) Patients with poor general condition caused by disease such as severe infection
2) Pregnant, breastfeeding , sexually active woman, or patients with no contraception.
3) Patients with severe diabetes mellitus
4) Patients registration to this study is deemed difficult due to mental disorders clinically relevant
5) Considered to be inappropriate for the participation in this study by the investigators
6) Patients unwilling to sign the consent form for participation
Target sample size 26

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasushi Mizukami
Organization Hokkaido Cancer Center
Division name Department of thoracic surgery
Zip code
Address 2-3-54, Kikusui 4-jo, Shiroishi-ku Sapporo-shi, Hokkaido, 003-0804, Japan
TEL 011-811-9111
Email mizukami@sap-cc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasushi Mizukami
Organization Hokkaido Cancer Center
Division name Department of thoracic surgery
Zip code
Address 2-3-54, Kikusui 4-jo, Shiroishi-ku Sapporo-shi, Hokkaido, 003-0804, Japan
TEL 011-811-9111
Homepage URL
Email mizukami@sap-cc.go.jp

Sponsor
Institute Hokkaido Cancer Center
Institute
Department

Funding Source
Organization Hokkaido Cancer Center
Organization
Division
Category of Funding Organization Other
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
2016 Year 11 Month 24 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 Enrolling by invitation
Date of protocol fixation
2016 Year 10 Month 14 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 24 Day
Last modified on
2017 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028751

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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