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

Preoperative Versus Intraoperative Transbronchial Dye Localization for Small Pulmonary Nodule : A Prospective Randomized Trial

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

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Hsin-Chu County
      • Taipei, Hsin-Chu County, Taiwan, 30059
        • Recruiting
        • National Taiwan University Hospital, Hsin-Chu Branch
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pre-op
Bronchoscopic dye marking under CBCT-augmented fluoroscopic guidance
Active Comparator: Intra-op
Bronchoscopic dye marking with ENB system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful localization
Time Frame: 2 days
Discrepancy from lesion to marking: less than 1 cm
2 days
Successful resection
Time Frame: 2 days
Lesion contained in first resected specimen
2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Localization duration
Time Frame: 1 day
Total time span of localization procedure
1 day
Total radiation exposure
Time Frame: 2 days
Radiation during entire localization procedure
2 days
Complication
Time Frame: 14 days
Procedure related complication
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2019

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

January 2, 2019

First Submitted That Met QC Criteria

January 2, 2019

First Posted (Actual)

January 4, 2019

Study Record Updates

Last Update Posted (Actual)

February 28, 2020

Last Update Submitted That Met QC Criteria

February 26, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 107-097-F

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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