UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036037 |
|---|---|
| Receipt number | 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 | 2024/03/04 15:03:57 |
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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 | Masanori |
| Middle name | |
| Last name | Tsuchida |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Thoracic and Cardiovascular Surgery
Zip code
951-8510
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata, Niigata
TEL
025-227-2243
masatsu@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Goto |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Thoracic and Cardiovascular Surgery
Zip code
951-8510
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata, Niigata
TEL
025-227-2243
Homepage URL
gotou-akt@umin.ac.jp
Sponsor or person
Institute
Niigata Chest Surgery Study Group
Institute
Department
Personal name
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
Ethics Committee of Niigata University
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata, Niigata
Tel
025-227-2625
ethics@adm.niigata-u.ac.jp
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
49
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
| 2018 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 14 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 10 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 28 | Day |
Last modified on
| 2024 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041050
