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Preoperative Stereoscopic Localization Versus Methylene Blue Localization in GGO Wedge Resection

Preoperative Stereoscopic Localization Versus Methylene Blue Localization in GGO Patients With Lung Wedge Resection:A Prospective Self-control Study.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03252210
Acronym
PSLVML
Enrollment
20
Registered
2017-08-17
Start date
2017-08-16
Completion date
2018-08-01
Last updated
2017-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thoracic Surgery, Video-Assisted

Keywords

Preoperative localization, Stereoscopic Localization, Wedge Resection, Ground Glass Opacity

Brief 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 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.

Interventions

PROCEDUREPreoperative Stereoscopic Localization

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 .

Sponsors

Guangdong Provincial People's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Masking description

Eventhough only one group of participants,different investigators perform two kinds of localization techniques.

Intervention model description

Single group self-control study

Eligibility

Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. Preoperative radiology revealed the solid component of GGO is larger than 5mm 2. Preoperative radiology revealed peripheral pulmonary nodule, with both size and depth less than 3 cm 3. Preoperative radiology revealed the distance from the lesion to the visceral pleura is larger than 5 mm

Exclusion criteria

1. Preoperative radiology revealed pneumonia or atelectasis 2. 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). 3. Bleeding tendency or anticoagulant use 4. Pregnancy or breast feeding 5. Patient who can not sign permit

Design outcomes

Primary

MeasureTime frameDescription
success rate of Stereoscopic Localization3 daySuccess localization means that the distance from lession to anchor point is less than 3.0 cm.

Secondary

MeasureTime frameDescription
Distance from A to B3 dayA: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
Distance from A to C3 dayA: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
Comparison between Stereoscopic Localization success rate and Methylene Blue Localization success rate3 dayTo evaluate the two kinds of Localization.Success localization means that the distance from lession to anchor point is less than 3.0 cm.
The success rate of wedge resection3 dayTo evaluate the accuracy rate of localization
Postoperative adverse event incidence rate1 monthsTo evaluate the incidence rate of pneumothorax or perilesional hemorrhage in participants
Distance from B to C3 dayB: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 .

Contacts

Primary ContactWen-Zhao Zhong, Ph.D
18820792959@163.com18820792959

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026