UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034261
Receipt number R000038954
Scientific Title Multicenter prospective observational study for the management of air leakage after pulmonary resection (ILO1805)
Date of disclosure of the study information 2018/09/25
Last modified on 2022/02/08 11:13:12

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Basic information

Public title

Multicenter prospective observational study for the management of air leakage after pulmonary resection (ILO1805)

Acronym

Multicenter prospective observational study for the management of air leakage after pulmonary resection (ILO1805)

Scientific Title

Multicenter prospective observational study for the management of air leakage after pulmonary resection (ILO1805)

Scientific Title:Acronym

Multicenter prospective observational study for the management of air leakage after pulmonary resection (ILO1805)

Region

Japan


Condition

Condition

Air leakage after pulmonary resection

Classification by specialty

Surgery in general Chest surgery Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the present trend for management of air leakage after pulmonary resection in Japan, and to inspect the feasibility of conducting prospective randomized controlled study by estimating the optimal management method with analyzing the period of postoperative air leakage of each methods (water seal, continuous suction, and using digital suction system).

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

The period of postoperative air leakage by each management methods (water seal, continuous suction, and using digital suction system).

Key secondary outcomes

1) Frequency in use of each management methods of postoperative air leakage
2) Occurrence rate of postoperative air leakage by operative procedures
3) Occurrence rate of prolonged (for more than 7days after surgery) air leakage


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The patients who were clinically diagnosed with pulmonary tumor and underwent complete resection (partial resection, segmentectomy, lobectomy, and bi-lobectomy)

Key exclusion criteria

1) The patients who underwent pneumonectomy.
2) The patients who underwent bronchoplasty or chest wall resection.
3) The patients who underwent surgical resection for the treatment of emphysema or inflammatory lung disease.
4) The patients who underwent surgery for the purpose of only biopsy, and were not achieved complete resection.
5) The patients who denied the registration for this study.

Target sample size

1200


Research contact person

Name of lead principal investigator

1st name Hiroyuki
Middle name
Last name Adachi

Organization

Kanto Rosai Hospital

Division name

Department of Thoracic Surgery

Zip code

211-8510

Address

1-1, Kizukisumiyoshi-cho, Nakahara-ku, Kawasaki, Japan

TEL

044-411-3131

Email

adachi-fam@white.plala.or.jp


Public contact

Name of contact person

1st name Hiroyuki
Middle name
Last name Adachi

Organization

Kanto Rosai Hospital

Division name

Department of Thoracic Surgery

Zip code

211-8510

Address

1-1, Kizukisumiyoshi-cho, Nakahara-ku, Kawasaki, Japan

TEL

044-411-3131

Homepage URL


Email

adachi-fam@white.plala.or.jp


Sponsor or person

Institute

International Lung-clinical-Research Organization

Institute

Department

Personal name



Funding Source

Organization

International Lung-clinical-Research Organization

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

IRB of Kanto-Rosai Hospital

Address

1-1, Kizukisumiyoshi-cho, Nakahara-ku, Kawasaki, Japan

Tel

044-411-3131

Email

h_adachi_no2@yahoo.co.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

埼玉県立循環器呼吸器病センター(埼玉県)、帝京大学付属溝口病院(神奈川県)、帝京大学附属病院(東京都)、奈良県立医科大学付属病院(奈良県)、浜松医科大学付属病院(静岡県)、山形県立中央病院(山形県)、焼津市立総合病院(静岡県)、浜松医療センター(静岡県)、大崎市民病院(宮城県)四国がんセンター(愛媛県)、昭和大学横浜市北部病院(神奈川県)、昭和大学附属病院(東京都)、北里大学附属病院(神奈川県)、神奈川県立循環器・呼吸器病センター(神奈川県)、関東労災病院(神奈川県)、済生会横浜市南部病院(神奈川県)、藤沢湘南台病院(神奈川県)、平塚共済病院(神奈川県)、横須賀共済病院(神奈川県)、横須賀市立うわまち病院(神奈川県)、横浜医療センター(神奈川県)、横浜市立大学附属病院(神奈川県)、横浜市立大学附属市民総合医療センター(神奈川県)、横浜南共済病院(神奈川県)、横浜労災病院(神奈川県)


Other administrative information

Date of disclosure of the study information

2018 Year 09 Month 25 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

2200

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

2018 Year 08 Month 14 Day

Date of IRB

2018 Year 08 Month 14 Day

Anticipated trial start date

2018 Year 09 Month 25 Day

Last follow-up date

2020 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete

2020 Year 09 Month 30 Day

Date analysis concluded

2021 Year 12 Month 31 Day


Other

Other related information

<Factors that will be registered>
Age, Gender, Patients' height, Body weight, Smoking history(Brinkman Index), Existence of COPD, Existence of IPF, The history of using steroid, Date of operation, Extent of lung resection, Existence of ittraopertive adhesion, Intraoperative use of Fibrin-glue, Devices that used in transection of interlobar fissure, Type and size of chest drainage tube, Final pathological diagnosis, The method of managing chest drainage tube, Pressure of continuous suction of chest tube, The type of chest drainage bag, The degree of air leakage at the time when the operation is just finished, The degree of air leakage at the morning of postoeprative day1, Date of changing the method of management of chest drainage, Date of disappearance of air leakage, Date of chest tube removal, Existence of prolonged air leakage, Occurence of pneumothorax after chest drain removal.


Management information

Registered date

2018 Year 09 Month 25 Day

Last modified on

2022 Year 02 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038954


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name