Preoperative Stereoscopic Localization Versus Methylene Blue Localization in GGO Wedge Resection (PSLVML)

August 14, 2017 updated by: Wen-zhao ZHONG, Guangdong Provincial People's Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stereoscopic Versus Methylene Blue

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
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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison between Stereoscopic Localization success rate and Methylene Blue Localization success rate
Time Frame: 3 day
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
Distance from A to B
Time Frame: 3 day
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
Distance from A to C
Time Frame: 3 day
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
Distance from B to C
Time Frame: 3 day
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
The success rate of wedge resection
Time Frame: 3 day
To evaluate the accuracy rate of localization
3 day
Postoperative adverse event incidence rate
Time Frame: 1 months
To evaluate the incidence rate of pneumothorax or perilesional hemorrhage in participants
1 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Investigators

  • Principal Investigator: Wen-Zhao Zhong, Ph.D, Guangdong Provincial People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 16, 2017

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

August 6, 2017

First Submitted That Met QC Criteria

August 14, 2017

First Posted (Actual)

August 17, 2017

Study Record Updates

Last Update Posted (Actual)

August 17, 2017

Last Update Submitted That Met QC Criteria

August 14, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PSL-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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