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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02908646
Other study ID # 2014PHB113
Secondary ID
Status Recruiting
Phase Phase 3
First received September 17, 2016
Last updated September 17, 2016
Start date June 2016
Est. completion date July 2017

Study information

Verified date September 2016
Source Peking University People's Hospital
Contact Xizhao Sui, MD
Email eastlifer@sina.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 72
Est. completion date July 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
microcoil localization
CT-guided localization by placing a microcoil into the lung parenchyma
hookwire localization
CT-guided localization by placing a hookwire into the lung parenchyma

Locations

Country Name City State
China Peking university people's hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary complications after CT-guided localization any complication occured after CT-guided localization 1 years Yes
Secondary major complications after CT-guided localization major complication refers to complication that need to be interfered before surgery 1 years Yes
Secondary success of the intervention of localization success of the intervention of CT guided localization by microcoil or hookwire 1 year No
Secondary success of the localization by thoracoscopic surgery success of the localization by thoracoscopic surgery under the guide of the planted microcoil or hookwire 1 year No
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