UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008031 |
|---|---|
| Receipt number | R000009457 |
| Scientific Title | Pre-operative bronchoscopic marking of small pulmonary lesions using virtual bronchoscopic navigation |
| Date of disclosure of the study information | 2012/05/28 |
| Last modified on | 2019/05/31 12:40:58 |
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Basic information
Public title
Pre-operative bronchoscopic marking of small pulmonary lesions using virtual bronchoscopic navigation
Acronym
Pre-operative bronchoscopic marking of small pulmonary lesions using virtual bronchoscopic navigation
Scientific Title
Pre-operative bronchoscopic marking of small pulmonary lesions using virtual bronchoscopic navigation
Scientific Title:Acronym
Pre-operative bronchoscopic marking of small pulmonary lesions using virtual bronchoscopic navigation
Region
| Japan |
Condition
Condition
Pulmonary neoplasms
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To overcome the limitation of conventional CT-guided marking including complications (air emborisms, bleeding, pneumothorax) adn technical limitations (mainly due to anatomical localization of the target), by using 3D virtual bronchoscopic navigation, bronchoscopic marking is conducted and the efficacy and safety will be examined.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Safety of bronchoscopic marking
2) Accuracy of marking
3) Efficacy as an aid for lung resection
Key secondary outcomes
Outcome of lung resection (resection with free margin) in pathology
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
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Brpmchoscopically inject indigo carmine (0.5-1ml)to peripheral lung tissue
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
Patients who have small (=<2cm in diameter) peripheral lung nodules that are hardly palpable, or lesions with ground glass opacity (regardless of the size) for which pre-operative marking is considered to be necessary based on clinical judgement.
Key exclusion criteria
Before the renewal of the protocol on March 2017: Those who have past or present medical history of asthma
After the renewal of the protocol on March 2017: None
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaaki Sato |
Organization
The University of Tokyo Hospital
Division name
Department of Thoracic Surgery
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
satom-sur@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaaki Sato |
Organization
The University of Tokyo Hospital
Division name
Department of Thoracic Surgery
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
http://cts.m.u-tokyo.ac.jp/column/val-map
satomasa@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
The University of Tokyo Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Jyuntendo University (Tokyo), Tokyo University (Tokyo), Niigata University (Niigata), Yamagata University (Yamagata), Tokyo Medical and Dental University (Tokyo), Tokyo Women's Medical University Yachiyo Medical Center (Tokyo), University of Occupational and Environmental Health (Fukuoka), Kitano Hospital (Osaka), Nagara Medical Center (Gifu), Okayama Rosai Hospital (Okayama), Shimane Prefectural Central Hospital (Shimane), Aizawa Hospital (Nagano), St. Luke's International Hospital (Tokyo), Hyogo Prefectural Amagasaki General Medcal Center (Hyogo), Matsue Red Cross Hospital (Shimane), Matsusaka City Hospital (Mie), NTT East Japan Kanto Hospital (Tokyo), Japan Red Cross Medical Centre (tokyo), Kokuho-Asahi General Hospital (Chiba), Nagasaki University Hospital (Nagasaki)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
京都大学医学部附属病院（京都府）,順天堂大学（東京都）、東京大学（東京都）、新潟大学（新潟県）、山形大学（山形県）、、東京医科歯科大学（東京都）、東京女子医大八千代医療センター（千葉県）、、産業医科大学（福岡県）、田附興風会医学研究所北野病院（大阪府）、長良医療センター（岐阜県）、岡山労災病院（岡山県）、島根県立中央病院（島根県）、相澤病院（長野県）、聖路加国際病院（東京都）、県立尼崎総合医療センター（兵庫県）、松江赤十字病院（島根県）、松阪市民病院（三重県）、ＮＴＴ東日本関東病院（東京都）、日本赤十字社医療センター（東京都）、総合病院国保旭中央病院（千葉県）、長崎大学医学部附属病院（長崎県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 28 | Day |
Related information
URL releasing protocol
http://cts.m.u-tokyo.ac.jp/column/val-map
Publication of results
Published
Result
URL related to results and publications
http://www.thoracic-kyoto-u.gr.jp/
Number of participants that the trial has enrolled
582
Results
The technique of preoperative bronchoscopic lung marking navigated by virtual bronchoscopy (currently called Virtual-Assisted Lung Mapping (VAL-MAP)) has shown broader application (lung wedge resection, segmentectomy), contributing to precise determination of resection lines with less complications (4 cases of minor pneumothoraces without any need of treatment among 100 cases) compared with conventional methods.
Results date posted
| 2019 | Year | 05 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2018 | Year | 06 | Month | 20 | Day |
Baseline Characteristics
Selection criteria included patients with pulmonary lesions anticipated to be difficult to identify at thoracoscopy and/or those undergoing sub-lobar lung resections requiring careful determination of resection margins.
Participant flow
Data were collected prospectively and, if needed, compared between the centre that originally developed VAL-MAP and 16 other centres.
Adverse events
Complications associated with VAL-MAP necessitating additional management occurred in four patients (0.8%) including pneumonia, fever and temporary exacerbation of pre-existing cerebral ischaemia. Minor complications included pneumothorax (3.6%), pneumomediastinum (1.2%) and alveolar haemorrhage (1.2%), with similar incidences between the orinitial centre and other centres.
Outcome measures
Five hundred patients underwent VAL-MAP with 1781 markings (3.6+/-1.2 marks/patient). Marks were identifiable during operation in approximately 90%, whereas the successful resection rate was approximately 99% in both groups, partly due to the mutually complementary marks. The contribution of VAL-MAP to surgical success was highly rated by surgeons resecting pure ground glass nodules (P<0.0001), tumours=<？5？mm (P=0.0016), and performing complex segmentectomy and wedge resection (P=0.0072).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2012 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 26 | Day |
Last modified on
| 2019 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009457
