Preoperative Computed Tomography-guided Localization for Lung Nodules: Localization Needle Versus Coil

January 16, 2022 updated by: Xuzhou Central Hospital
Preoperative computed tomography-guided localization can improve technical success rates associated with sublobar lung nodule resection conducted via video-assisted thoracoscopic surgery. This study sought to compare the clinical efficacy of computed tomography-guided localization needle and coil insertion as approaches to preoperative lung nodule localization.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Lung nodules are frequently diagnosed and often exhibit a high potential for malignancy such that they are commonly diagnosed and treated via video-assisted thoracic surgery approaches. Preoperative computed tomography-guided localization strategies are commonly employed to improve the successful rate of video-assisted thoracic surgery-guided sublobar (wedge or segmental) resection procedures. One recent meta-analysis found coil localization to be associated with the lowest rate of complications of tested localization materials. Hook-wire has also been widely used due to its simple placement approaches. However, a number of recent reports have suggested that hook-wire insertion approaches are associated with an increased potential for frequent and potentially severe complications.

The use of a novel lung nodule localization needle strategy based on the modification of this previously described hook-wire approach has recently been employed in clinical contexts. Such localization needles have the potential to incur lower rates of detachment and complications relative to the hook-wire strategy without resulting in an increase in localization difficulty. The relative clinical efficacy of localization needle-based strategies compared to that of other localization materials, however, has yet to be established in the context of lung nodule localization.

Study Type

Interventional

Enrollment (Anticipated)

100

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 Locations

  • China
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221009
        • Xuzhou Central Hospital

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with lung nodules;
  2. Patients with an intermediate-to-high risk of malignancy as established based upon radiological and clinical findings.

Exclusion Criteria:

  1. Lung nodule < 5 mm;
  2. Calcification nodules;
  3. Lung nodule which decreased in size at time of follow-up;
  4. Patients with distant metastases or other severe comorbidities.

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: Localization needle insertion
Patients undergo localization needle insertion on day 1.
Device: Localization needle
A localization needle which is used for preoperative localization of lung nodules.
Active Comparator: Coil insertion
Patients undergo coil insertion on day 1.
Device: Coil
A coil which is used for preoperative localization of lung nodules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success of localization
Time Frame: From the date of randomization until the date of first documented failure localization from any cause, assessed up to 7 day.
Lung nodule localization is considered technically successful if the coil tail or marked line can be visible during the video-assisted thoracoscopic surgery. procedure
From the date of randomization until the date of first documented failure localization from any cause, assessed up to 7 day.

Collaborators and Investigators

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

Sponsor

Xuzhou Central Hospital

Investigators

  • Principal Investigator: Xian-Chi Li, MD, Xuzhou Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 14, 2022

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

December 21, 2021

First Submitted That Met QC Criteria

December 21, 2021

First Posted (Actual)

January 11, 2022

Study Record Updates

Last Update Posted (Actual)

January 19, 2022

Last Update Submitted That Met QC Criteria

January 16, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20211221005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make individual participant data available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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