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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036037
Receipt No. R000041050
Scientific Title A multicenter randomized phase II trial evaluating the efficacy and safety of intrapericardial left superior pulmonary vein ligation or division for prevention of thrombosis in the stump
Date of disclosure of the study information 2019/03/01
Last modified on 2019/02/28

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Basic information
Public title A multicenter randomized phase II trial evaluating the efficacy and safety of intrapericardial left superior pulmonary vein ligation or division for prevention of thrombosis in the stump
Acronym A phase II trial examining the prevention of thrombosis in the left superior pulmonary vein by intrapericardial ligation or division
Scientific Title A multicenter randomized phase II trial evaluating the efficacy and safety of intrapericardial left superior pulmonary vein ligation or division for prevention of thrombosis in the stump
Scientific Title:Acronym A phase II trial examining the prevention of thrombosis in the left superior pulmonary vein by intrapericardial ligation or division
Region
Japan

Condition
Condition malignant tumor of the lung
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy and safety of intrapericardial left superior pulmonary vein ligation or division for prevention of thrombosis in the stump, comparing with intra thoracic division in lung cancer patients of left upper lobe
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Incidence rates of thrombosis in the left superior pulmonary vein stump (within 30 days after surgery)
Key secondary outcomes Incidence rates of thrombosis in the left superior pulmonary vein stump (over 31 days after surgery)
Operative time
Bleeding volume
length of thoracic drainage tube placement
length of hospital stay
Adverse event rates

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 A: intrathoracic division
Interventions/Control_2 B: intrapericardial ligation or division
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
85 years-old >
Gender Male and Female
Key inclusion criteria 1.Lung cancer patients of left upper lobe
2. Patients who are scheduled for left upper lobectomy via thoracotomy or thoracoscopic approach
3. 20 years <= and 85 years >
4. ECOG performance status of 0 or 1
5. No following surgical history
i) left thoracotomy
ii) left thoracoscopic resection of lung, esophagus, and mediastinum (except for thoracoscopic resection of bullae)
iii) Heart and great vessel surgery (except for thoracic endovascular aortic repair)
6. Satisfy the following conditions
i) hilum and mediastinum of the operative site are not included in the radiotherapy field
ii) no past history of more than Grade2 radiation pneumonitis at the site of operation
7. Written informed consent
Key exclusion criteria 1. The common trunk of the left pulmonary vein
2. Contrast media allergy
3. Renal function disorder or preoperative creatinine level is higher than 1.2 mg/dL
4. Asthma
5. Using biguanide hypoglycemia drug
6. Active infection requiring systemic therapy
7. Female during pregnancy, within 28 days of postparturition, or during lactation and male expecting partner's pregnancy
8. Severe psychological disorder
9. Atrial fibrillation
10. History of myocardial infarction or attack of angina pectoris within the past 3 weeks
11. Uncontrollable valvular disease, dilated cardiomyopathy, and hypertrophic cardiomyopathy
12. Interstitial pneumonitis
13. a participating surgeon judged that the patient was not appropriate candidate for the study
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanori Tuchida
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Division of Thoracic and Cardiovascular Surgery
Zip code
Address 1-757 Asahimachi-dori, Chuo-ku, Niigata, Niigata
TEL 025-227-2243
Email masatsu@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Goto
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Division of Thoracic and Cardiovascular Surgery
Zip code
Address 1-757 Asahimachi-dori, Chuo-ku, Niigata, Niigata
TEL 025-227-2243
Homepage URL
Email gotou-akt@umin.ac.jp

Sponsor
Institute Niigata Chest Surgery Study Group
Institute
Department

Funding Source
Organization Division of Thoracic and Cardiovascular Surgery, Niigata University Graduate School of Medical and Dental Sciences
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 長岡赤十字病院(新潟県)/Nagaoka Red Cross Hospital
西新潟中央病院(新潟県)/Nishi-Niigata Chuo National Hopital
魚沼基幹病院(新潟県)/Uonuma Kikan Hospital
長岡中央綜合病院(新潟県)/Nagaoka Chuo General Hospital
新潟県立中央病院(新潟県)/Niigata Prefectural Central Hospital
新潟県立新発田病院(新潟県)/Niigata Prefectural Shibata Hospital

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 01 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 Preinitiation
Date of protocol fixation
2018 Year 12 Month 28 Day
Date of IRB
Anticipated trial start date
2019 Year 04 Month 01 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
2019 Year 02 Month 28 Day
Last modified on
2019 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041050

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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