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Clinical Trials/NCT02908646
NCT02908646UnknownPhase 3

Comparing of Computed Tomography Guided Microcoil Localization and Hook Wire Localization for Pulmonary Small Nodules and Ground-glass Opacity Prior to Thoracoscopic Resection

Peking University People's Hospital1 site in 1 country72 target enrollmentStarted: June 2016Last updated:
Conditions

Trial Snapshot

Phase
Phase 3
Enrollment
72
Locations
1
Primary Endpoint
complications after CT-guided localization

Study Overview

Brief Summary

Both of microcoil localization and hookwire localization have been proved as good preoperative CT(computed tomography)-guided techniques to guide VATS resection for the diagnosis of small peripheral pulmonary nodules technique to guide VATS resection for the diagnosis of small peripheral pulmonary nodules. The objective of this study is to determine if microcoil localization for pulmonary nodules can be safer than hookwire localization

Detailed Description

Both of microcoil localization and hookwire localization have been proved as good preoperative CT-guided techniques to guide VATS resection for the diagnosis of small peripheral pulmonary nodules technique to guide VATS(video assisted thoracoscopic surgery) resection for the diagnosis of small peripheral pulmonary nodules. Compared with the commonly used hook wire, the platinum microcoil can be retained in the patients'body and the configuration of which had an effect in reducing the severity of complications. The fibered microcoil may promote blood coagulation of the surrounding lung tissues, block the needle pathway, and decrease the severity of pneumothorax and bleeding caused by the puncture needle, which has been proven in animal experiments. The objective of this study is to determine if microcoil localization for pulmonary nodules can be safer than hookwire localization

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • solid nodules with a diameter ≤1 cm and distance to visceral pleura ≥0.5 cm, -ground-glass nodules,
  • part-solid ground-glass nodules, with a solid portion ≤1 cm and distance to the visceral pleura ≥1 cm.
  • peripheral nodules amenable to thoracoscopic wedge excision of the nodules.

Exclusion Criteria

  • Patients combined with pneumothorax.
  • Patients combined with pleural effusion.
  • Patients with history of hemoptysis.
  • Patients with medical condition that the radiologist and surgeon disagree for inclusion.

Outcomes

Primary Outcomes

complications after CT-guided localization

Time Frame: 1 years

any complication occured after CT-guided localization

Secondary Outcomes

  • major complications after CT-guided localization(1 years)
  • success of the localization by thoracoscopic surgery(1 year)
  • success of the intervention of localization(1 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jun Wang

Pro

Peking University People's Hospital

Study Sites (1)

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