Lipiodol Localization for Ground-glass-opacity Minimal Surgery

Not Applicable

Completed

• Conditions: Pulmonary Lesion With Ground-glass-opacity
• Interventions: Procedure: Hookwire; Drug: Lipiodol

• Registration Number: NCT02180568
• Lead Sponsor: Severance Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-07-01
• Study First Submitted QC: 2014-07-01
• Study First Posted: 2014-07-02
• Primary Completion: 2016-12
• Study Completion: 2017-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-20
• Last Update Posted: 2018-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hookwire	Hookwire	Hookwire-guided lung localization technique
Lipiodol	Lipiodol	Lipiodol-guided lung localization technique

Primary Outcome Measures

Name	Time	Method
Procedure success rate	one day	Procedure success was defined as marking (lipiodol or hook-wire) the GGO lesion within 1 cm without pleural leakage of lipiodol or dislodgement of the hook-wire.

Secondary Outcome Measures

Name	Time	Method
Procedure time	1 hour	Total procedure time for lung localization
Complication rate	one day	Procedure-related complications such as pneumothorax, lung hemorrhage, hemoptysis, air-embolism and death
Safety resection margin	1 hour	The safety specimen resection margin was categorized either as positive (grossly positive (R2), microscopically positive if tumor was at the inked surface (R1)), or negative (microscopically negative if there was no tumor at the inked surface (R0))
Surgery time	12 hours	Surgery time for obtaining wedge resection specimen

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of