Thoracic Surgery, Video-AssistedPSLVMLNCT03252210
Preoperative Stereoscopic Localization Versus Methylene Blue Localization in GGO Wedge Resection
A study testing Preoperative Stereoscopic Localization in people with Thoracic Surgery, Video-Assisted, run by Guangdong Provincial People's Hospital.
Trial summary
This study evaluates the feasibility，accuracy and safety of Preoperative Stereoscopic Localization Versus Methylene Blue Localization in GGO Wedge Resection. In the first stage，participants will receive both Preoperative Stereoscopic Localization and Methylene Blue Localization .In the second stage,participants only… Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Thoracic Surgery, Video-Assisted
- What is being tested?
- Preoperative Stereoscopic Localization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 16 Aug 2017to 1 Aug 2018
- Phase
- Interventional
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Preoperative radiology revealed the solid component of GGO is larger than 5mm
- Preoperative radiology revealed peripheral pulmonary nodule, with both size and depth less than 3 cm
- Preoperative radiology revealed the distance from the lesion to the visceral pleura is larger than 5 mm
Who cannot join
- Preoperative radiology revealed pneumonia or atelectasis
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
- Bleeding tendency or anticoagulant use
- Pregnancy or breast feeding
- Patient who can not sign permit
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Preoperative Stereoscopic Localization Versus Methylene Blue Localization in GGO Patients With Lung Wedge Resection:A Prospective Self-control Study.
This study evaluates the feasibility，accuracy and safety of Preoperative Stereoscopic Localization Versus Methylene Blue Localization in GGO Wedge Resection. In the first stage，participants will receive both Preoperative Stereoscopic Localization and Methylene Blue Localization .In the second stage,participants only receive Preoperative Stereoscopic Localization for Wedge Resection.
Read the detailed description
More and more Ground Glass Opacity（GGO）are detected because of the early screening.According to Fleischner Society, for some solid GGO, surgical resection should be performed if the solid component is larger than 5mm.With the development of video-assisted thoracoscopic surgery (VATS) techniques, minimally invasive thoracic surgery has evolved considerably over the last three decades.However, localizing the small sized pulmonary nodules during VATS is challenging when there is no change in visceral pleura.
Several traditional techniques have been described to localize peripheral pulmonary nodules, including preoperative CT-guided tattooing with methylene blue, CT scan guided spiral/hook wire placement and marking with radio-opaque materials. The traditional marking method have its strong and weak points. For the strong point, It provide a credible and precise nodule location to the surgeon. For the weak points:(1)a potential risk of pneumothorax and hemothorax.(2)Methylene blue have a tendency to diffuse over a large area during surgical preparation until the nodule's location is confirmed.(3)The Preoperative localization technique would need more time for the Preoperative preparation, which would be reduce the transport's efficiency.(4)It would occupy the resource of CT's usage.(5)Some of the methods ,such as methylene blue, maybe interference with the Pathological diagnosis.(6)These methods are all invasive operation, would Cause the patients' psychological fear.
In order to avoid these weak points，the investigators use a new localization technique which has three basic steps: 1.Confirm the nodule's location in pulmonary segments. 2.Measure the distance between the nodule and anatomic landmarks on CT. 3. Estimate the changes of the distance between the nodule and anatomic landmarks after the alveolar atelectasis. The investigators have already succeed in some case.But,the further study is needed.Hence,the investigators designed a prospective study of Preoperative Stereoscopic Localization Versus Methylene Blue Localization in GGO Wedge Resection.Then,the investigators evaluate the feasibility，accuracy and safety of Preoperative Stereoscopic Localization Versus Methylene Blue Localization in GGO Wedge Resection.
- Conditions
- Thoracic Surgery, Video-Assisted
- Being tested
- Preoperative Stereoscopic Localization
- Keywords
- Preoperative localization, Stereoscopic Localization, Wedge Resection, Ground Glass Opacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Stereoscopic LocalizationProcedure or surgery
1.Confirm the nodule's location and measure the distance between the nodule and anatomic landmarks from the CT scan. 2.According to the results of the first step，confirm the needle puncture site of the chest wall. 3.After general anesthesia and Patient positioning are completed, the needle is then inserted via the needle puncture site .
| Study group | Role | What they receive |
|---|---|---|
| Stereoscopic Versus Methylene Blue | Experimental | In the same participant,we perform both Stereoscopic and Methylene Blue localization。Then，compare the distance between the methylene blue's anchor point and the location of lesion,stereoscopic Localization's anchor point and the location of lesion,methylene blue's anchor point and stereoscopic Localization's anchor point.
Post Hoc Multiple Comparisons Receives: Procedure: Preoperative Stereoscopic Localization |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate of Stereoscopic Localization
Success localization means that the distance from lession to anchor point is less than 3.0 cm.
Measured: 3 day
Secondary outcomes (6)
Comparison between Stereoscopic Localization success rate and Methylene Blue Localization success rate
To evaluate the two kinds of Localization.Success localization means that the distance from lession to anchor point is less than 3.0 cm.
Measured: 3 day
Distance from A to B
A:lession B：methylene blue anchor point To evaluate the accuracy of methylene blue localization.Measure the distance from lession to the methylene blue localization anchor point
Measured: 3 day
Distance from A to C
A:lession C：Stereoscopic Localization anchor point To evaluate the accuracy of Stereoscopic Localization localization.Measure the distance from lession to the Stereoscopic Localization localization anchor point
Measured: 3 day
Distance from B to C
B：methylene blue anchor point C：Stereoscopic Localization anchor point To evaluate the two kinds of Localization.Measure the distance from methylene blue localization anchor point to the stereoscopic localization anchor point .
Measured: 3 day
The success rate of wedge resection
To evaluate the accuracy rate of localization
Measured: 3 day
Postoperative adverse event incidence rate
To evaluate the incidence rate of pneumothorax or perilesional hemorrhage in participants
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start16 Aug 2017 (estimated)
- Primary completion1 Aug 2018 (estimated)
- Study completion1 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Thoracic Surgery, Video-AssistedStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group self-control study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-zhao ZHONG, Guangdong Provincial People's Hospital
- Investigators
- Wen-Zhao Zhong, Ph.D, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252210
- Sponsor's protocol ID
- PSL-1
- Acronym
- PSLVML
- Status last verified
- Aug 2017
- First submitted
- 6 Aug 2017
- Last updated
- 17 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kleedehn M, Kim DH, Lee FT, Lubner MG, Robbins JB, Ziemlewicz TJ, Hinshaw JL. Preoperative Pulmonary Nodule Localization: A Comparison of Methylene Blue and Hookwire Techniques. AJR Am J Roentgenol. 2016 Dec;207(6):1334-1339. doi: 10.2214/AJR.16.16272. Epub 2016 Sep 22.
PubMed 27657546Wicky S, Mayor B, Schnyder P. Methylene blue localizations of pulmonary nodules under CT-guidance: a new procedure used before thoracoscopic resections. Int Surg. 1997 Jan-Mar;82(1):15-7.
PubMed 9189791Wicky S, Mayor B, Cuttat JF, Schnyder P. CT-guided localizations of pulmonary nodules with methylene blue injections for thoracoscopic resections. Chest. 1994 Nov;106(5):1326-8. doi: 10.1378/chest.106.5.1326.
PubMed 7956378
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Stereoscopic Localization Versus Methylene Blue Localization in GGO Patients With Lung Wedge Resection:A Prospective Self-control Study.
- ClinicalTrials.gov ID
- NCT03252210
- Acronym / sponsor ID
- PSLVML / PSL-1
- Conditions
- Thoracic Surgery, Video-Assisted
- Keywords
- Preoperative localization, Stereoscopic Localization, Wedge Resection, Ground Glass Opacity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 16 Aug 2017 (estimated)
- Primary completion
- 1 Aug 2018 (estimated)
- Study completion
- 1 Aug 2018 (estimated)
- First posted
- 17 Aug 2017 (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 evaluates the feasibility，accuracy and safety of Preoperative Stereoscopic Localization Versus Methylene Blue Localization in GGO Wedge Resection. In the first stage，participants will receive both Preoperative Stereoscopic Localization and Methylene Blue Localization .In the second stage,participants only receive Preoperative Stereoscopic Localization for Wedge Resection.
Detailed description
More and more Ground Glass Opacity（GGO）are detected because of the early screening.According to Fleischner Society, for some solid GGO, surgical resection should be performed if the solid component is larger than 5mm.With the development of video-assisted thoracoscopic surgery (VATS) techniques, minimally invasive thoracic surgery has evolved considerably over the last three decades.However, localizing the small sized pulmonary nodules during VATS is challenging when there is no change in visceral pleura.
Several traditional techniques have been described to localize peripheral pulmonary nodules, including preoperative CT-guided tattooing with methylene blue, CT scan guided spiral/hook wire placement and marking with radio-opaque materials. The traditional marking method have its strong and weak points. For the strong point, It provide a credible and precise nodule location to the surgeon. For the weak points:(1)a potential risk of pneumothorax and hemothorax.(2)Methylene blue have a tendency to diffuse over a large area during surgical preparation until the nodule's location is confirmed.(3)The Preoperative localization technique would need more time for the Preoperative preparation, which would be reduce the transport's efficiency.(4)It would occupy the resource of CT's usage.(5)Some of the methods ,such as methylene blue, maybe interference with the Pathological diagnosis.(6)These methods are all invasive operation, would Cause the patients' psychological fear.
In order to avoid these weak points，the investigators use a new localization technique which has three basic steps: 1.Confirm the nodule's location in pulmonary segments. 2.Measure the distance between the nodule and anatomic landmarks on CT. 3. Estimate the changes of the distance between the nodule and anatomic landmarks after the alveolar atelectasis. The investigators have already succeed in some case.But,the further study is needed.Hence,the investigators designed a prospective study of Preoperative Stereoscopic Localization Versus Methylene Blue Localization in GGO Wedge Resection.Then,the investigators evaluate the feasibility，accuracy and safety of Preoperative Stereoscopic Localization Versus Methylene Blue Localization in GGO Wedge Resection.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group self-control study
| Arm | Type | Receives |
|---|---|---|
| Stereoscopic Versus Methylene Blue | Experimental | Procedure: Preoperative Stereoscopic LocalizationIn the same participant,we perform both Stereoscopic and Methylene Blue localization。Then，compare the distance between the methylene blue's anchor point and the location of lesion,stereoscopic Localization's anchor point and the location of lesion,methylene blue's anchor point and stereoscopic Localization's anchor point. Post Hoc Multiple Comparisons |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Preoperative radiology revealed the solid component of GGO is larger than 5mm
- Preoperative radiology revealed peripheral pulmonary nodule, with both size and depth less than 3 cm
- Preoperative radiology revealed the distance from the lesion to the visceral pleura is larger than 5 mm
Key exclusion criteria (5 listed)
- Preoperative radiology revealed pneumonia or atelectasis
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
- Bleeding tendency or anticoagulant use
- Pregnancy or breast feeding
- Patient who can not sign permit
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 |
|---|---|---|
| Preoperative Stereoscopic Localization1.Confirm the nodule's location and measure the distance between the nodule and anatomic landmarks from the CT scan. 2.According to the results of the first step，confirm the needle puncture site of the chest wall. 3.After general anesthesia and Patient positioning are completed, the needle is then inserted via the needle puncture site . | Procedure or surgery | Stereoscopic Versus Methylene Blue |
Primary outcome
success rate of Stereoscopic Localization
Time frame: 3 day
Success localization means that the distance from lession to anchor point is less than 3.0 cm.
6 secondary outcomes
Comparison between Stereoscopic Localization success rate and Methylene Blue Localization success rate
Time frame: 3 day
Distance from A to B
Time frame: 3 day
Distance from A to C
Time frame: 3 day
Distance from B to C
Time frame: 3 day
The success rate of wedge resection
Time frame: 3 day
Postoperative adverse event incidence rate
Time frame: 1 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2017.
- Background: PubMed 27657546Kleedehn M, Kim DH, Lee FT, Lubner MG, Robbins JB, Ziemlewicz TJ, Hinshaw JL. Preoperative Pulmonary Nodule Localization: A Comparison of Methylene Blue and Hookwire Techniques. AJR Am J Roentgenol. 2016 Dec;207(6):1334-1339. doi: 10.2214/AJR.16.16272. Epub 2016 Sep 22.
- Background: PubMed 9189791Wicky S, Mayor B, Schnyder P. Methylene blue localizations of pulmonary nodules under CT-guidance: a new procedure used before thoracoscopic resections. Int Surg. 1997 Jan-Mar;82(1):15-7.
- Background: PubMed 7956378Wicky S, Mayor B, Cuttat JF, Schnyder P. CT-guided localizations of pulmonary nodules with methylene blue injections for thoracoscopic resections. Chest. 1994 Nov;106(5):1326-8. doi: 10.1378/chest.106.5.1326.
- 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.
Wen-Zhao Zhong, Ph.D principal investigator
Guangdong Provincial People's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative Stereoscopic Localization in people with Thoracic Surgery, Video-Assisted, run by Guangdong Provincial People's 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 5 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 17 Aug 2017. 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 Wen-Zhao Zhong, Ph.D (18820792959, 18820792959@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate of Stereoscopic Localization (time frame: 3 day). 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 NCT03252210, which also lists 3 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 17 Aug 2017.