Preoperative Stereoscopic Localization Versus Methylene Blue Localization in GGO Wedge Resection

Thoracic Surgery, Video-Assisted Clinical Trial

— PSLVML  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03252210
• Other study ID #: PSL-1
• Status: Not yet recruiting
• Phase: N/A
• First received: August 6, 2017
• Last updated: August 14, 2017
• Start date: August 16, 2017
• Est. completion date: August 1, 2018

Study information

• Verified date: August 2017
• Source: Guangdong Provincial People's Hospital
• Contact: Wen-Zhao Zhong, Ph.D
• Phone: 18820792959
• Email: 18820792959[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 receive Preoperative Stereoscopic Localization for Wedge Resection.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: August 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Thoracic Surgery, Video-Assisted

Intervention

Procedure:
• Preoperative 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 .

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital

References & Publications (3)

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. Epub 2016 Sep 22. — View Citation

Wicky 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. — View Citation

Wicky 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	success rate of Stereoscopic Localization	Success localization means that the distance from lession to anchor point is less than 3.0 cm.	3 day
Secondary	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.	3 day
Secondary	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	3 day
Secondary	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	3 day
Secondary	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 .	3 day
Secondary	The success rate of wedge resection	To evaluate the accuracy rate of localization	3 day
Secondary	Postoperative adverse event incidence rate	To evaluate the incidence rate of pneumothorax or perilesional hemorrhage in participants	1 months