Localization for Deep Lung Nodules: Microcoil Versus Contrast Injection

Preoperative Localization With Microcoil Placement or Contrast Injection for Deep-seated Pulmonary Nodule : A Prospective Randomized Trial

In recent years, the development of low-dose pulmonary computed tomography screening has led to the discovery of many small pulmonary nodules in the early stages.

Surgical resection is still the main treatment for those suspected malignant lesions. In the face of such small pulmonary nodules, accurate preoperative localization has become the key to successful resection, and the deep-seated nodules are the most challenging parts. Because the deep-seated nodules cannot be localized by surface dye injection, however, it is necessary to place a fiducial marker (such as a microcoil) or contrast medium injection in combination with intraoperative fluoroscopy to ensure adequate resection of the deep-seated nodules. . This study will be carried out at the Hsinchu Branch of National Taiwan University Hospital. It is expected that 60 patients with pulmonary nodules with a depth larger than 2 cm will be randomly assigned into two groups. One group will receive microcoil placement, and the other group will receive contrast medium injection. The primary goal of the study was to compare the localization duration of the two groups of patients, the total dose of radiation exposure during localization and the incidence of location-related complications, and the secondary goals were the results of the surgical procedure, including the surgical duration.

Study Overview

• Status: Unknown
• Conditions: Lung Cancer
• Intervention / Treatment: Device: Microcoil; Drug: Lipiodol

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Hsin-Chu County
    • Taipei, Hsin-Chu County, Taiwan, 30059
      • Recruiting
      • National Taiwan University Hospital, Hsin-Chu Branch
      • Contact: Chiu-kuei Nien; Phone Number: 886-3-5326151; Email: hch01215@hch.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Deep lung lesions

Exclusion Criteria:

Emphysema COPD Previous ilpislateral surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Microcoil; Needle localization for deep-seated lung nodules with microcoil placement	Device: Microcoil; Needle localization with microcoil
Active Comparator: Contrast; Needle localization for deep-seated lung nodules with contrast injection	Drug: Lipiodol; Needle localization with contrast injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure success rate	Procedure success is defined as marking (lipiodol or hook-wire) the GGO lesion within 1 cm without pleural leakage of lipiodol or dislodgement of the hook-wire. The procedure success rate is calculated as follows: procedure success rate (%) = (number of procedure success / number of total procedure) × 100.	1 day
Successful localization for surgery	Localization contribute to surgery	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure-related complication rate	Incidence of complications during needle procedure, The procedure-related complication rate is calculated as follows: procedure-related complication rate (%) = (number of procedure-related complication / number of total procedure) × 100.	1 day
Duration of the localization procedure	From start of needle procedure to withdraw of the needle (minutes)	1 day
Duration of wedge resection	From start of surgery to completion of pulmonary wedge resection (minutes)	1 day
Surgical margin of wedge resection	Distance from pulmonary lesion to resection margin of the specimen	1 day

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital Hsin-Chu Branch

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: July 12, 2018
• First Submitted That Met QC Criteria: August 3, 2018
• First Posted (Actual): August 6, 2018

Study Record Updates

• Last Update Posted (Actual): December 4, 2018
• Last Update Submitted That Met QC Criteria: November 30, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Thoracoscopy; CT-guided; Fiducial marker; Deep-seated; Needle localization
• Additional Relevant MeSH Terms: Antineoplastic Agents; Ethiodized Oil
• Other Study ID Numbers: 107-032-F

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No