NCT03252210

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2017

Completed
10 days until next milestone

Study Start

First participant enrolled

August 16, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 17, 2017

Status Verified

August 1, 2017

Enrollment Period

12 months

First QC Date

August 6, 2017

Last Update Submit

August 14, 2017

Conditions

Thoracic Surgery, Video-Assisted

Keywords

Preoperative localizationStereoscopic LocalizationWedge ResectionGround Glass Opacity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Comparison between Stereoscopic Localization success rate and Methylene Blue Localization success rate

    3 day

  • Distance from A to B

    3 day

  • Distance from A to C

    3 day

  • Distance from B to C

    3 day

  • The success rate of wedge resection

    3 day

  • +1 more secondary outcomes

Study Arms (1)

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

Procedure: Preoperative Stereoscopic Localization

Interventions

Preoperative Stereoscopic LocalizationPROCEDURE

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 .

Stereoscopic Versus Methylene Blue

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. doi: 10.2214/AJR.16.16272. Epub 2016 Sep 22.

    PMID: 27657546BACKGROUND

  • 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.

    PMID: 9189791BACKGROUND

  • 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.

    PMID: 7956378BACKGROUND

Study Officials

  • Wen-Zhao Zhong, Ph.D

    Guangdong Provincial People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wen-Zhao Zhong, Ph.D

CONTACT

1882079295918820792959@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Eventhough only one group of participants，different investigators perform two kinds of localization techniques.
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Single group self-control study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy director of Guangdong lung cancer institute

Study Record Dates

First Submitted

August 6, 2017

First Posted

August 17, 2017

Study Start

August 16, 2017

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

August 17, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share