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

Xuzhou Central Hospital (Xuzhou Fourth People's Hospital)

Status: Unknown

Conditions: Lung; Node

Treatments: Device: Coil; Device: Localization needle

Study type: Interventional

Funder types: Other

Identifiers

NCT05183945

20211221005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Localization needle insertion

Experimental group

Description:

Patients undergo localization needle insertion on day 1.

Treatment:

Device: Localization needle

Coil insertion

Active Comparator group

Description:

Patients undergo coil insertion on day 1.

Treatment:

Device: Coil