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

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

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

Study Overview

• Status: Unknown
• Conditions: Thoracic Surgery
• Intervention / Treatment: Procedure: microcoil localization; Procedure: 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 Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University People's Hospital
    • Contact: Jun Wang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: microcoil; patients who plan for microcoil localization	Procedure: microcoil localization; CT-guided localization by placing a microcoil into the lung parenchyma
Placebo Comparator: hookwire; patients who plan for hookwire localization	Procedure: hookwire localization; CT-guided localization by placing a hookwire into the lung parenchyma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complications after CT-guided localization	any complication occured after CT-guided localization	1 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
major complications after CT-guided localization	major complication refers to complication that need to be interfered before surgery	1 years
success of the intervention of localization	success of the intervention of CT guided localization by microcoil or hookwire	1 year
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

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Principal Investigator: Hui Zhao, MD, Department of Thoracic Surgery, Center for Mini-invasive Thoracic Surgery, People's Hospital, Peking University

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: September 17, 2016
• First Submitted That Met QC Criteria: September 17, 2016
• First Posted (Estimate): September 21, 2016

Study Record Updates

• Last Update Posted (Estimate): September 21, 2016
• Last Update Submitted That Met QC Criteria: September 17, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 2014PHB113

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no plan to make individual participant data (IPD) available