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

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-14

Study Completion Date

2022-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung; Node

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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Localization needle insertion

Patients undergo localization needle insertion on day 1.

Group Type EXPERIMENTAL

Localization needle

Intervention Type DEVICE

A localization needle which is used for preoperative localization of lung nodules.

Coil insertion

Patients undergo coil insertion on day 1.

Group Type ACTIVE_COMPARATOR

Coil

Intervention Type DEVICE

A coil which is used for preoperative localization of lung nodules.

Interventions

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Localization needle

A localization needle which is used for preoperative localization of lung nodules.

Intervention Type DEVICE

Coil

A coil which is used for preoperative localization of lung nodules.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No