NCT03617029

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

December 4, 2018

Status Verified

November 1, 2018

Enrollment Period

9 months

First QC Date

July 12, 2018

Last Update Submit

November 30, 2018

Conditions

Lung Cancer

Keywords

Deep-seatedNeedle localizationCT-guidedThoracoscopyFiducial marker

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Procedure-related complication rate

    1 day

  • Duration of the localization procedure

    1 day

  • Duration of wedge resection

    1 day

  • Surgical margin of wedge resection

    1 day

Study Arms (2)

Microcoil

EXPERIMENTAL

Needle localization for deep-seated lung nodules with microcoil placement

Device: Microcoil

Contrast

ACTIVE COMPARATOR

Needle localization for deep-seated lung nodules with contrast injection

Drug: Lipiodol

Interventions

MicrocoilDEVICE

Needle localization with microcoil

Microcoil
LipiodolDRUG

Needle localization with contrast injection

Contrast

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Deep lung lesions

You may not qualify if:

  • Emphysema COPD Previous ilpislateral surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital, Hsin-Chu Branch

Taipei, Hsin-Chu County, 30059, Taiwan

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Ethiodized Oil

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Iodized OilPlant OilsOilsLipidsPlant PreparationsBiological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2018

First Posted

August 6, 2018

Study Start

January 1, 2019

Primary Completion

October 1, 2019

Study Completion

December 1, 2019

Last Updated

December 4, 2018

Record last verified: 2018-11

Locations

TW(1)