UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033974
Receipt number R000038746
Scientific Title A phase I trial examining the safety of major left lung resection with left atrial appendectomy for left lung cancer patients with atrial fibrillation
Date of disclosure of the study information 2018/09/03
Last modified on 2019/02/28 12:13:41

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Basic information

Public title

A phase I trial examining the safety of major left lung resection with left atrial appendectomy for left lung cancer patients with atrial fibrillation

Acronym

A phase I trial examining the safety of major left lung resection with left atrial appendectomy

Scientific Title

A phase I trial examining the safety of major left lung resection with left atrial appendectomy for left lung cancer patients with atrial fibrillation

Scientific Title:Acronym

A phase I trial examining the safety of major left lung resection with left atrial appendectomy

Region

Japan


Condition

Condition

malignant tumor of the lung
atrial fibrillation

Classification by specialty

Cardiology Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To examine the safety of major left lung resection with left atrial appendectomy for left lung cancer patients with non-valvular atrial fibrillation

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Adverse events rate

Key secondary outcomes

Operative time
Bleeding volume
length of drainage tube placement
length of hospital stay


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

1.Patients who are scheduled for surgery for left malignant pulmonary tumor (suspected or confirmed)
2.surgical procedure: segmentectomy >=
3.non-valvular atrial fibrillation
4.20 years <=
5.ECOG performance status of 0 or 1
6. 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)
7.Written informed consent

Key exclusion criteria

1.Active infection requiring systemic therapy
2. Female during pregnancy, within 28 days of postparturition, or during lactation and male expecting partner's pregnancy
3.Severe psychological disorder
4.History of myocardial infarction or attack of angina pectoris within the past 3 weeks
5.Uncontrollable valvular disease, dilated cardiomyopathy, and hypertrophic cardiomyopathy
6.Interstitial pneumonitis
7.thrombus in left atrial appendage
8.No radiotherapy at the site of operation
9. a participating surgeon judged that the patient was not appropriate candidate for the study

Target sample size

5


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 or person

Institute

Niigata University Graduate School of Medical and Dental Sciences

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


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

2018 Year 09 Month 03 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

2018 Year 09 Month 03 Day

Date of IRB


Anticipated trial start date

2019 Year 03 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

Adverse events
Operative time
Bleeding volume
length of drainage tube placement
length of hospital stay


Management information

Registered date

2018 Year 08 Month 31 Day

Last modified on

2019 Year 02 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038746


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name