Intra-op vs Pre-op Transbronchial Localization for Small Lung Nodule

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-08

Study Completion Date

2023-06-30

Brief Summary

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Comparing pre-operative transbronchial localization under augmented fluoroscopy and intra-operative transbronchial localization using electromagnetic navigation bronchoscopy system for small lung nodules.

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Detailed Description

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Using electromagnetic navigation bronchoscopy (ENB), transbronchial localization can be performed in the operating room (OR) under general anesthesia without extra radiation exposure, which is expected to reduce the discomfort for the patient during localization. This study will be carried out at the Hsinchu Branch of National Taiwan University Hospital. It is expected that 40 patients with pulmonary nodules will be randomly assigned into two groups. One group will receive bronchoscopic dye localization in the hybrid examination room equipped with cone-beam computed tomography, and the other group will receive ENB-guided dye localization in OR. 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.

Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pre-op

Group Type EXPERIMENTAL

AF-guided endobronchial marking

Intervention Type PROCEDURE

Bronchoscopic dye marking under CBCT-augmented fluoroscopic guidance

Intra-op

Group Type ACTIVE_COMPARATOR

ENB-guided endobronchial marking

Intervention Type DEVICE

Bronchoscopic dye marking with ENB system

Interventions

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AF-guided endobronchial marking

Bronchoscopic dye marking under CBCT-augmented fluoroscopic guidance

Intervention Type PROCEDURE

ENB-guided endobronchial marking

Bronchoscopic dye marking with ENB system

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

A. One of each: lung nodule size less than 1 cm; depth more than 2 cm; GGO lesion B. 20\~90 years old C. sign permit

Exclusion Criteria

A. Previous emphysema, TB, COPD B. Previous ipsilateral thoracic surgery C. Bleeding tendency D. Heart failure, cirrhosis, CKD E. Pregnancy or breast feeding F. Immunocompromised G. Severe infection H. Unable to sign permit

Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No