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Recruitment status Terminated
Unique ID issued by UMIN UMIN000004030
Receipt No. R000004846
Scientific Title Randomized Trial between Buttressed Versus Nonbuttressed Stapling in Pulmonary Lobectomy
Date of disclosure of the study information 2010/08/11
Last modified on 2012/02/13

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Basic information
Public title Randomized Trial between Buttressed Versus Nonbuttressed Stapling in Pulmonary Lobectomy
Acronym Randomized Trial between Buttressed Versus Nonbuttressed Stapling in Pulmonary Lobectomy
Scientific Title Randomized Trial between Buttressed Versus Nonbuttressed Stapling in Pulmonary Lobectomy
Scientific Title:Acronym Randomized Trial between Buttressed Versus Nonbuttressed Stapling in Pulmonary Lobectomy
Region
Japan

Condition
Condition Scheduled to undergo pulmonary lobectomy
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 Endo GIA Duet TRS to a current international standard of care group using a conventional stapler in patients undergoing pulmonary lobectomy surgery, using a randomized comparative study of the frequency of intraoperative air leak.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Frequency of intraoperative air leak
Key secondary outcomes Days of hospitalization, postoperative duration of air leak, duration of drain placement, frequency of intraoperative sealant use, percent occurrence of intraoperative adverse events, percent occurrence of postoperative adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are 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
Device,equipment Maneuver
Interventions/Control_1 A: Test treatment group using Endo GIA Duet TRS
Interventions/Control_2 B: Current international standard of care group using conventional stapler
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 1) Aged 20 years or older
2) Eligible for pulmonary lobectomy
3) Scheduled to undergo pulmonary lobectomy
4) Performance status 0-1 (ECOG classification)
5) No history of lung surgery
6) Healthy organ function
7) Scheduled for staple surgery
8) Wiiling and able to participate in the study procedures and able to understand and sign the informed consent
Key exclusion criteria 1) Has suffered thoracic trauma or has previously undergone lung surgery
2) Has an active bacterial infection or fungal infection
3) Undergoing continuing systemic administration (intravenous or oral) of steroids
4) Complicated by uncontrolled diabetes mellitus
5) Allergic to nickel chromium
6) Patient participation is judged difficult due to study 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 140

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
Email

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
Email

Sponsor
Institute Covidien Japan Inc.
Institute
Department

Funding Source
Organization Covidien Japan Inc.
Organization
Division
Category of Funding Organization Profit organization
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 YES
Study ID_1 NCT01241617
Org. issuing International ID_1 ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 順天堂大学医学部附属順天堂医院(東京)

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 11 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 Terminated
Date of protocol fixation
2010 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
2012 Year 02 Month 01 Day
Date of closure to data entry
2012 Year 02 Month 01 Day
Date trial data considered complete
2012 Year 02 Month 01 Day
Date analysis concluded
2012 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 08 Month 11 Day
Last modified on
2012 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004846

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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