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Comparing of Microcoil Localization and Hook Wire Localization for Resectable Pulmonary Small Nodules

P

Peking University

Status and phase

Unknown
Phase 3

Conditions

Thoracic Surgery

Treatments

Procedure: hookwire localization
Procedure: microcoil localization

Study type

Interventional

Funder types

Other

Identifiers

NCT02908646
2014PHB113

Details and patient eligibility

About

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

Full 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

Enrollment

72 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

72 participants in 2 patient groups, including a placebo group

microcoil
Experimental group
Description:
patients who plan for microcoil localization
Treatment:
Procedure: microcoil localization
hookwire
Placebo Comparator group
Description:
patients who plan for hookwire localization
Treatment:
Procedure: hookwire localization

Trial contacts and locations

1

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Central trial contact

Hui Zhao, MD; Xizhao Sui, MD

Data sourced from clinicaltrials.gov

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