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

Not Applicable

• Conditions: Lung; Node
• Interventions: Device: Localization needle; Device: Coil

• Registration Number: NCT05183945
• Lead Sponsor: Xuzhou Central Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-12-21
• Study First Submitted QC: 2021-12-21
• Status Verified: 2022-01
• Study First Posted: 2022-01-11
• Study Start: 2022-01-14
• Last Update Submitted: 2022-01-16
• Last Update Posted: 2022-01-19
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Localization needle insertion	Localization needle	Patients undergo localization needle insertion on day 1.
Coil insertion	Coil	Patients undergo coil insertion on day 1.

Primary Outcome Measures

Name	Time	Method
Technical success of localization	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

Trial Locations

Locations (1)

Xuzhou Central Hospital; 🇨🇳 Xuzhou, Jiangsu, China