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

NCT05183945 | Unknown DMC

• 1 other identifier: 20211221005
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung; Node

Keywords

Lung nodule; Localization; Coil; Needle

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Localization needle insertion

EXPERIMENTAL

Patients undergo localization needle insertion on day 1.

Device: Localization needle

Coil insertion

ACTIVE COMPARATOR

Patients undergo coil insertion on day 1.

Device: Coil

Interventions

Localization needle DEVICE

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

Localization needle insertion

Coil DEVICE

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

Coil insertion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with lung nodules;
• Patients with an intermediate-to-high risk of malignancy as established based upon radiological and clinical findings.

You may not qualify if:

• Lung nodule \< 5 mm;
• Calcification nodules;
• Lung nodule which decreased in size at time of follow-up;
• Patients with distant metastases or other severe comorbidities.

Sponsors & Collaborators

• Xuzhou Central Hospital: lead

Study Sites (1)

Xuzhou Central Hospital

Xuzhou, Jiangsu, 221009, China

Location

Related 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.

  PMID: 29135327 BACKGROUND

Study Officials

• Xian-Chi Li, MD

  Xuzhou Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 11, 2022
• Study Start: January 14, 2022
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: January 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)