Clinical trial NCT03252210: Preoperative Stereoscopic Localization Versus Methylene Blue Localization in GGO Wedge Resection
Official title: Preoperative Stereoscopic Localization Versus Methylene Blue Localization in GGO Patients With Lung Wedge Resection:A Prospective Self-control Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thoracic Surgery, Video-Assisted
Keywords: Preoperative localization
Stereoscopic Localization
Wedge Resection
Ground Glass Opacity
Lead sponsor: GuangdongPPH
Sponsor class: UNKNOWN
First posted: 2017-08-17
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group self-control study
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: success rate of Stereoscopic Localization
timeFrame: 3 day
Secondary outcomes:
measure: Comparison between Stereoscopic Localization success rate and Methylene Blue Localization success rate
timeFrame: 3 day
measure: Distance from A to B
timeFrame: 3 day
measure: Distance from A to C
timeFrame: 3 day
measure: Distance from B to C
timeFrame: 3 day
measure: The success rate of wedge resection
timeFrame: 3 day
measure: Postoperative adverse event incidence rate
timeFrame: 1 months
Other outcomes:
Locations:
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Wen-Zhao Zhong, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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. doi: 10.1378/chest.106.5.1326.