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

NCT ID: NCT02908646

Last Updated: 2016-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-07-31

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

Conditions

Thoracic Surgery

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

microcoil

patients who plan for microcoil localization

Group Type: EXPERIMENTAL

microcoil localization

Intervention Type: PROCEDURE

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

hookwire

patients who plan for hookwire localization

Group Type: PLACEBO_COMPARATOR

hookwire localization

Intervention Type: PROCEDURE

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

Interventions

microcoil localization

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

Intervention Type: PROCEDURE

hookwire localization

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jun Wang

Pro

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hui Zhao, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Thoracic Surgery, Center for Mini-invasive Thoracic Surgery, People's Hospital, Peking University

Locations

Peking university people's hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xizhao Sui, MD

Role: CONTACT

eastlifer@sina.com

Hui Zhao, MD

Role: CONTACT

zhaohui@pukph.edu.cn

Facility Contacts

Jun Wang, MD

Role: primary

Other Identifiers

2014PHB113

Identifier Type: -

Identifier Source: org_study_id