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

Lung; Node Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05183945
• Other study ID #: 20211221005
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 14, 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: January 2022
• Source: Xuzhou Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung; Node

Intervention

Device:
• Localization needle
A localization needle which is used for preoperative localization of lung nodules.
• Coil
A coil which is used for preoperative localization of lung nodules.

Locations

Country	Name	City	State
China	Xuzhou Central Hospital	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Xuzhou Central Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Fu YF, Zhang M, Wu WB, Wang T. Coil Localization-Guided Video-Assisted Thoracoscopic Surgery for Lung Nodules. J Laparoendosc Adv Surg Tech A. 2018 Mar;28(3):292-297. doi: 10.1089/lap.2017.0484. Epub 2017 Nov 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical success of localization	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.