Lipiodol Localization for Ground-glass-opacity Minimal Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-12-31

Brief Summary

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The study object is to demonstrate the usefulness and safety of lipiodol localization technique for individuals undergoing ground-glass opacity (GGO) Video-assisted thoracic surgery (VATS) resection compared to hook wire localization technique. A total of 250 participants will be enrolled in a 1:1 fashion to Lipiodol or Hook-wire groups. If the aims of this study are achieved, the use of lipiodol localization technique will be widespread their application for localization of non-palpable pulmonary lesions that are indicated for VATS resection.

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Detailed Description

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Conditions

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Pulmonary Lesion With Ground-glass-opacity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Lipiodol

Lipiodol-guided lung localization technique

Group Type EXPERIMENTAL

Lipiodol

Intervention Type PROCEDURE

Lipiodol-guided lung localization technique

Lipiodol

Intervention Type DRUG

Hookwire

Hookwire-guided lung localization technique

Group Type ACTIVE_COMPARATOR

Hookwire

Intervention Type PROCEDURE

Hookwire-guided lung localization technique

Interventions

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Lipiodol

Lipiodol-guided lung localization technique

Intervention Type PROCEDURE

Hookwire

Hookwire-guided lung localization technique

Intervention Type PROCEDURE

Lipiodol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Consenting adult patients ≥ 20 years of age
* Pulmonary lesion with a ground glass opacity(GGO)component of more than 50%
* Patient with lesion size less than 3cm
* Persistence or growth of the established lesion within a three month period
* Patient who are not contraindicated to surgery
* Patients who are willing to sign the informed consent form

Exclusion Criteria

* Patients with solid pulmonary lesion
* Patients with multiple GGOs need multiple localization
* Patients who are contraindicated to surgery
* Patients who behave in an uncooperative manner
* Unwilling or unable to give informed consent
* Pregnant women

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No