UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036921
Receipt number R000042073
Scientific Title Efficacy of intraoperative ultrasonography for the detection of small lung nodules
Date of disclosure of the study information 2019/06/02
Last modified on 2021/07/31 10:35:53

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Basic information

Public title

Efficacy of intraoperative ultrasonography for the detection of small lung nodules

Acronym

Efficacy of intraoperative ultrasonography for the detection of small lung nodules

Scientific Title

Efficacy of intraoperative ultrasonography for the detection of small lung nodules

Scientific Title:Acronym

Efficacy of intraoperative ultrasonography for the detection of small lung nodules

Region

Japan


Condition

Condition

lung cancer, metastatic lung tumor, benign lung nodule

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the intrathoracic pressure and ultrasound setting suitable for performing intraoperative ultrasonography for lung nodules, and to examine the usefulness of intraoperative ultrasonographic lung puncture marking

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

detection of lung nodules under intraoperative ultrasonography during surgery

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

To perform intraoperative ultrasonography to identify pulmonary nodules in the thoracic cavity under positive thoracic pressure

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1) lung nodules less than 20mm, which is planned for lung wedge resection
2) palpation with small thoracotomy requires site identification normally
3) ECOG = 0-1
4) following data criteria is met:
WBC 3,000-12,000/mm3
Hemoglobin more than 9.0g/dl
Platelet more than 10x104/mm3
AST less than 100IU/L, ALT less than 100IU/L
Total Bilirubin less than 1.5mg/dL
serum Creatinine less than 1.5mg/dL

Key exclusion criteria

1) cases where it may be difficult to identify even by palpation with small thoracotomy if it is not possible to visualize by intraoperative ultrasonography.
2) High-risk patients who can not tolerate extended general anesthesia
3) Patients with interstitial pneumonia
4) Patients with emphsematous change
5) Patients that the attending physician judged inappropriate to carry out this study

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Yoshikane
Middle name
Last name Yamauchi

Organization

Teikyo University School of medicine

Division name

Department of Surgery

Zip code

1738605

Address

Kaga 2-11-1, Itabashi, Tokyo

TEL

+81339641211

Email

yoshikaney@2004.jukuin.keio.ac.jp


Public contact

Name of contact person

1st name Yoshikane
Middle name
Last name Yamauchi

Organization

Teikyo University School of medicine

Division name

Department of Surgery

Zip code

1738605

Address

Kaga 2-11-1, Itabashi, Tokyo

TEL

+81339641211

Homepage URL


Email

yoshikaney@2004.jukuin.keio.ac.jp


Sponsor or person

Institute

Department of Surgery, Teikyo University School of medicine

Institute

Department

Personal name



Funding Source

Organization

Teikyo University School of medicine

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

Teikyo University Ethics comittee

Address

Kaga 2-11-1, Itabashi, Tokyo

Tel

+81 3 3964 7256

Email

turb-office@teikyo-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

帝京大学医学部附属病院(東京都)


Other administrative information

Date of disclosure of the study information

2019 Year 06 Month 02 Day


Related information

URL releasing protocol

http://www.ncbi.nlm.nih.gov/pubmed/33079334

Publication of results

Partially published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/33079334

Number of participants that the trial has enrolled

20

Results

22 tumors (85%) were detectable with ultrasonography after lung collapse. Of these 22 tumors, 16 were well-depicted, while six were poorly delineated. tumor dimension of the mediastinal window (MD) showed the largest area under the receiver operating characteristic curve (0.81), and tumors with an MD less than 6 mm had a high risk of difficult localization using ultrasonography.

Results date posted

2021 Year 06 Month 03 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2020 Year 10 Month 20 Day

Baseline Characteristics

patinets who undergo thoracoscopic pulmonary wedge resection in our institution

Participant flow

Patients scheduled for thoracoscopic pneumonectomy will be explained the details of the clinical trial and those who receive approval will be enrolled.

Adverse events

not in particular

Outcome measures

tumor detection rate

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 09 Month 01 Day

Date of IRB

2016 Year 08 Month 15 Day

Anticipated trial start date

2016 Year 09 Month 01 Day

Last follow-up date

2019 Year 08 Month 31 Day

Date of closure to data entry

2019 Year 12 Month 31 Day

Date trial data considered complete

2019 Year 12 Month 31 Day

Date analysis concluded

2020 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2019 Year 06 Month 02 Day

Last modified on

2021 Year 07 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042073


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name