UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016715 |
|---|---|
| Receipt number | R000019365 |
| Scientific Title | Prospective Randomized Trial of the Effectiveness of Managing Postoperative Air Leak between Electronic Versus Traditional Chest Drainage System in Pulmonary Resection |
| Date of disclosure of the study information | 2015/03/05 |
| Last modified on | 2019/03/08 09:27:32 |
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Basic information
Public title
Prospective Randomized Trial of the Effectiveness of Managing Postoperative Air Leak between Electronic Versus Traditional Chest Drainage System in Pulmonary Resection
Acronym
Prospective Randomized Trial of the Effectiveness of Managing Postoperative Air Leak between Electronic Versus Traditional Chest Drainage System in Pulmonary Resection
Scientific Title
Prospective Randomized Trial of the Effectiveness of Managing Postoperative Air Leak between Electronic Versus Traditional Chest Drainage System in Pulmonary Resection
Scientific Title:Acronym
Prospective Randomized Trial of the Effectiveness of Managing Postoperative Air Leak between Electronic Versus Traditional Chest Drainage System in Pulmonary Resection
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study was to confirm the superiority of a test treatment group using a digital monitoring thoracic drainage system (Thopaz group) to a current clinical standard of care group using a conventional water seal or continuous suction thoracic drainage (conventional thoracic drainage group) in patients undergoing pulmonary resection associated with more than segmentectomy excluding pneumonectomy, using a randomized comparative study of the duration of postoperative drain placement (enable for earlier removal of drain).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Duration of drain placement (days)
Key secondary outcomes
Percent occurrence of intraoperative air leak (at the time of the first postoperative leak test), frequency of intraoperative sealant use and its type, percent occurrence of postoperative air leak (at the time of entering postoperative recovery room or ICU), duration of postoperative air leak (days), frequency of postoperative pleurodesis, days of hospitalization (days), and percent occurrence of postoperative adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients using Thopaz
Interventions/Control_2
Conventional drainage group
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
Patients who have no history of ipsilateral lung surgery, scheduled to undergo pulmonary resection associated with more than segmentectomy excluding pneumonectomy, and fulfill below criteria are eligible.
1)Patients scheduled to undergo pulmonary resection associated with more than segmentectomy excluding pneumonectomy
2)More than 800 mL of predicted postoperative forced expiratory volume in one second (ppoFEV1)
(ppoFEV1 = Preoperative FEV1 x (number of segment - number of segment to be resected)/number of segment)
3)Performance Status 0-1 (ECOG classification)
4)Above 20 years old
5)Consent from the patient for participating in the study is obtained
Key exclusion criteria
1)Has previously undergone ipsilateral lung surgery
2)Has an active lung infection (bacterial infection or fungal infection)
3)Undergoing continuing systemic administration (oral or intravenous) of steroids
4)Complicated by uncontrolled diabetes mellitus
(Uncontrolled: urinary glucose of 10 g or more per day or fasting blood glucose of 150 mg/dL or more even under insulin treatment)
5)Requiring anticoagulant therapy (continuous intravenous drip of heparin) in the perioperative period
6)Patient participation in the study is judged difficult due to complications related to a psychiatric disorder or psychological symptoms
7)Judged unsuitable for study participation by the investigator for any other reason
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Suzuki |
Organization
Juntendo University School of Medicine
Division name
General Thoracic Surgery
Zip code
Address
1-3, Hongo 3-chome, Bunkyo-ku, Tokyo, 113-8431, Japan
TEL
03-3813-3111
kjsuzuki@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuya Takamochi |
Organization
Juntendo University School of Medicine
Division name
General Thoracic Surgery
Zip code
Address
1-3, Hongo 3-chome, Bunkyo-ku, Tokyo, 113-8431, Japan
TEL
03-3813-3111
Homepage URL
ktakamo@juntendo.ac.jp
Sponsor or person
Institute
General Thoracic Surgery, Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Medela AG
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Switzerland
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
| 2015 | Year | 03 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2014 | Year | 12 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 03 | Day |
Date of closure to data entry
| 2016 | Year | 08 | Month | 03 | Day |
Date trial data considered complete
| 2016 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 05 | Day |
Last modified on
| 2019 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019365
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| Registered date | File name |
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