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

Phase 3

• Conditions: Thoracic Surgery
• Interventions: Procedure: microcoil localization; Procedure: hookwire localization

• Registration Number: NCT02908646
• Lead Sponsor: Peking University People's Hospital

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 Timeline

• Study Start: 2016-06
• Status Verified: 2016-09
• Study First Submitted: 2016-09-17
• Study First Submitted QC: 2016-09-17
• Last Update Submitted: 2016-09-17
• Study First Posted: 2016-09-21
• Last Update Posted: 2016-09-21
• Primary Completion: 2017-06
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
microcoil	microcoil localization	patients who plan for microcoil localization
hookwire	hookwire localization	patients who plan for hookwire localization

Primary Outcome Measures

Name	Time	Method
complications after CT-guided localization	1 years	any complication occured after CT-guided localization

Secondary Outcome Measures

Name	Time	Method
major complications after CT-guided localization	1 years	major complication refers to complication that need to be interfered before surgery
success of the localization by thoracoscopic surgery	1 year	success of the localization by thoracoscopic surgery under the guide of the planted microcoil or hookwire
success of the intervention of localization	1 year	success of the intervention of CT guided localization by microcoil or hookwire

Trial Locations

Locations (1)

Peking university people's hospital; 🇨🇳 Beijing, China