Localization for Deep Lung Nodules: Microcoil Versus Contrast Injection

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03617029
• Other study ID #: 107-032-F
• Status: Recruiting
• Phase: N/A
• Start date: January 2019
• Est. completion date: December 2019

Study information

• Verified date: November 2018
• Source: National Taiwan University Hospital Hsin-Chu Branch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

Deep lung lesions

Exclusion Criteria:

Emphysema COPD Previous ilpislateral surgery

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Device:
• Microcoil
Needle localization with microcoil

Drug:
• Lipiodol
Needle localization with contrast injection

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital, Hsin-Chu Branch	Taipei	Hsin-Chu County

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital Hsin-Chu Branch

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Successful localization for surgery	Localization contribute to surgery	1 day
Secondary	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
Secondary	Duration of the localization procedure	From start of needle procedure to withdraw of the needle (minutes)	1 day
Secondary	Duration of wedge resection	From start of surgery to completion of pulmonary wedge resection (minutes)	1 day
Secondary	Surgical margin of wedge resection	Distance from pulmonary lesion to resection margin of the specimen	1 day