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
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
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
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
