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

Thoracic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02908646
• Other study ID #: 2014PHB113
• 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

• Thoracic Surgery

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