Clinical trial NCT05183945: Preoperative Computed Tomography-guided Localization for Lung Nodules: Localization Needle Versus Coil
Official title: Preoperative Computed Tomography-guided Localization for Lung Nodules: Localization Needle Versus Coil
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung; Node
Keywords: Lung nodule
Localization
Coil
Needle
Lead sponsor: Xuzhou Central Hospital
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Technical success of localization
timeFrame: From the date of randomization until the date of first documented failure localization from any cause, assessed up to 7 day.
Secondary outcomes:
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
Study officials:
affiliation: Xuzhou Central Hospital
name: Xian-Chi Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.