UltrasonographyNCT03599505
Intraoperative Ultrasonographic Localization of Pulmonary Nodules in VATS
An observational study of Ultrasonography, run by Shanghai Chest Hospital.
Trial summary
This study is conducted to explore the feasibility and value of Intraoperative ultrasonographic localization of pulmonary nodules in video-assisted thoracoscopic surgery (VATS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ultrasonography
- What is being tested?
- localization group
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jul 2018to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients older than 18 year-old with chest CT showing pulmonary nodule that need to undergo VATS will be enrolled in the study. Patient with severe cardiopulmonary dysfunction and other indications that can't receive VATS will be excluded.
Who may be able to join
- Patients who are older than 18 year-old.
- Chest CT shows pulmonary nodule suspected to be malignant that need to undergo VATS.
- Patients who have good compliance and sign informed consent.
Who cannot join
- Patient with severe asthma and pulmonary fibrosis.
- Refusal of participation.
- Severe cardiopulmonary dysfunction and other indications that can't receive VATS.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Intraoperative Ultrasonographic Localization of Pulmonary Nodules in Video-assisted Thoracoscopic Surgery
This study is conducted to explore the feasibility and value of Intraoperative ultrasonographic localization of pulmonary nodules in video-assisted thoracoscopic surgery (VATS).
Read the detailed description
The study is designed as a single center prospective trial. The participating center is Department of Ultrasound, Shanghai Chest Hospital, Shanghai Jiao Tong University, China. The study is expected to enroll 200 patients. The feasibility and value of Intraoperative ultrasonographic localization of pulmonary nodules in VATS will be explored. The accuracy rate of localization will be evaluated using gray scale mode and elastography mode. Intraoperative ultrasonographic localization will be performed using an ultrasound system (HI VISON Ascendus), which is equipped with a 5-10MHz mechanical probe (EUP-OL531).
- Conditions
- Ultrasonography
- Being tested
- localization group
- Keywords
- intraoperative ultrasonographic localization, pulmonary nodules, video-assisted thoracoscopic surgery
- Medical subject headings
- Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
localization groupProcedure or surgery
Intraoperative ultrasonographic localization will be performed using an ultrasound system (HI VISON Ascendus), which is equipped with a 5-10MHz mechanical probe (EUP-OL531). The accuracy rate of localization will be evaluated using gray scale mode and elastography mode.
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy rate of localization
The accuracy rate of localization will be evaluated using gray scale mode and elastography mode using pathology as a reference.
Measured: one year
Secondary outcomes (3)
Correlation of lesion size and localization
Whether lesion size affects localization will be explored in the study.
Measured: one year
Correlation of distance between the lesion and pleura and localization
Whether distance between the lesion and pleura affects localization will be explored.
Measured: one year
Time of localization
The time of intraoperative ultrasonographic localization will be recorded.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study startJul 2018 (estimated)
- Primary completionJul 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for UltrasonographyStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Lei, Shanghai Chest Hospital
- Investigators
- Lei Wang, MD, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599505
- Sponsor's protocol ID
- Chest008
- Status last verified
- Jul 2018
- First submitted
- 21 Jun 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kondo R, Yoshida K, Hamanaka K, Hashizume M, Ushiyama T, Hyogotani A, Kurai M, Kawakami S, Fukushima M, Amano J. Intraoperative ultrasonographic localization of pulmonary ground-glass opacities. J Thorac Cardiovasc Surg. 2009 Oct;138(4):837-42. doi: 10.1016/j.jtcvs.2009.02.002. Epub 2009 Mar 26.
PubMed 19660350Mattioli S, D'Ovidio F, Daddi N, Ferruzzi L, Pilotti V, Ruffato A, Bolzani R, Gavelli G. Transthoracic endosonography for the intraoperative localization of lung nodules. Ann Thorac Surg. 2005 Feb;79(2):443-9; discussion 443-9. doi: 10.1016/j.athoracsur.2004.07.087.
PubMed 15680811Nakashima S, Watanabe A, Obama T, Yamada G, Takahashi H, Higami T. Need for preoperative computed tomography-guided localization in video-assisted thoracoscopic surgery pulmonary resections of metastatic pulmonary nodules. Ann Thorac Surg. 2010 Jan;89(1):212-8. doi: 10.1016/j.athoracsur.2009.09.075.
PubMed 20103238Pittet O, Christodoulou M, Pezzetta E, Schmidt S, Schnyder P, Ris HB. Video-assisted thoracoscopic resection of a small pulmonary nodule after computed tomography-guided localization with a hook-wire system. Experience in 45 consecutive patients. World J Surg. 2007 Mar;31(3):575-8. doi: 10.1007/s00268-006-0343-7.
PubMed 17318707Chen W, Chen L, Yang S, Chen Z, Qian G, Zhang S, Jing J. A novel technique for localization of small pulmonary nodules. Chest. 2007 May;131(5):1526-31. doi: 10.1378/chest.06-1017.
PubMed 17494801
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Ultrasonographic Localization of Pulmonary Nodules in Video-assisted Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT03599505
- Acronym / sponsor ID
- Chest008
- Conditions
- Ultrasonography
- Keywords
- intraoperative ultrasonographic localization, pulmonary nodules, video-assisted thoracoscopic surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- Jul 2018 (estimated)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is conducted to explore the feasibility and value of Intraoperative ultrasonographic localization of pulmonary nodules in video-assisted thoracoscopic surgery (VATS).
Detailed description
The study is designed as a single center prospective trial. The participating center is Department of Ultrasound, Shanghai Chest Hospital, Shanghai Jiao Tong University, China. The study is expected to enroll 200 patients. The feasibility and value of Intraoperative ultrasonographic localization of pulmonary nodules in VATS will be explored. The accuracy rate of localization will be evaluated using gray scale mode and elastography mode. Intraoperative ultrasonographic localization will be performed using an ultrasound system (HI VISON Ascendus), which is equipped with a 5-10MHz mechanical probe (EUP-OL531).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 year-old with chest CT showing pulmonary nodule that need to undergo VATS will be enrolled in the study. Patient with severe cardiopulmonary dysfunction and other indications that can't receive VATS will be excluded.
Key inclusion criteria (3 listed)
- Patients who are older than 18 year-old.
- Chest CT shows pulmonary nodule suspected to be malignant that need to undergo VATS.
- Patients who have good compliance and sign informed consent.
Key exclusion criteria (3 listed)
- Patient with severe asthma and pulmonary fibrosis.
- Refusal of participation.
- Severe cardiopulmonary dysfunction and other indications that can't receive VATS.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| localization groupIntraoperative ultrasonographic localization will be performed using an ultrasound system (HI VISON Ascendus), which is equipped with a 5-10MHz mechanical probe (EUP-OL531). The accuracy rate of localization will be evaluated using gray scale mode and elastography mode. | Procedure or surgery | – |
Primary outcome
The accuracy rate of localization
Time frame: one year
The accuracy rate of localization will be evaluated using gray scale mode and elastography mode using pathology as a reference.
3 secondary outcomes
Correlation of lesion size and localization
Time frame: one year
Correlation of distance between the lesion and pleura and localization
Time frame: one year
Time of localization
Time frame: one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Background: PubMed 19660350Kondo R, Yoshida K, Hamanaka K, Hashizume M, Ushiyama T, Hyogotani A, Kurai M, Kawakami S, Fukushima M, Amano J. Intraoperative ultrasonographic localization of pulmonary ground-glass opacities. J Thorac Cardiovasc Surg. 2009 Oct;138(4):837-42. doi: 10.1016/j.jtcvs.2009.02.002. Epub 2009 Mar 26.
- Background: PubMed 15680811Mattioli S, D'Ovidio F, Daddi N, Ferruzzi L, Pilotti V, Ruffato A, Bolzani R, Gavelli G. Transthoracic endosonography for the intraoperative localization of lung nodules. Ann Thorac Surg. 2005 Feb;79(2):443-9; discussion 443-9. doi: 10.1016/j.athoracsur.2004.07.087.
- Background: PubMed 20103238Nakashima S, Watanabe A, Obama T, Yamada G, Takahashi H, Higami T. Need for preoperative computed tomography-guided localization in video-assisted thoracoscopic surgery pulmonary resections of metastatic pulmonary nodules. Ann Thorac Surg. 2010 Jan;89(1):212-8. doi: 10.1016/j.athoracsur.2009.09.075.
- Background: PubMed 17318707Pittet O, Christodoulou M, Pezzetta E, Schmidt S, Schnyder P, Ris HB. Video-assisted thoracoscopic resection of a small pulmonary nodule after computed tomography-guided localization with a hook-wire system. Experience in 45 consecutive patients. World J Surg. 2007 Mar;31(3):575-8. doi: 10.1007/s00268-006-0343-7.
- Background: PubMed 17494801Chen W, Chen L, Yang S, Chen Z, Qian G, Zhang S, Jing J. A novel technique for localization of small pulmonary nodules. Chest. 2007 May;131(5):1526-31. doi: 10.1378/chest.06-1017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lei Wang, MD principal investigator
Shanghai Chest Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasonography, run by Shanghai Chest Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Wang, MD (86-021-22200000 ext. 1416, 13917985547@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy rate of localization (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03599505, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2018.