UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000008031
Receipt No. 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 (Ver. 13)

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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
Last 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
Email satom-sur@h.u-tokyo.ac.jp

Public contact
1st 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
Email satomasa@kuhp.kyoto-u.ac.jp

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009457