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

NCT02908646 | Unknown Phase 3

• 1 other identifier: 2014PHB113
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Thoracic Surgery

Outcome Measures

Primary Outcomes (1)

• complications after CT-guided localization

  any complication occured after CT-guided localization

  1 years

Secondary Outcomes (3)

• major complications after CT-guided localization

  1 years

• success of the intervention of localization

  1 year

• success of the localization by thoracoscopic surgery

  1 year

Study Arms (2)

microcoil

EXPERIMENTAL

patients who plan for microcoil localization

Procedure: microcoil localization

hookwire

PLACEBO COMPARATOR

patients who plan for hookwire localization

Procedure: hookwire localization

Interventions

microcoil localization PROCEDURE

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

microcoil

hookwire localization PROCEDURE

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

hookwire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients combined with pneumothorax.
• Patients combined with pleural effusion.
• Patients with history of hemoptysis.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking university people's hospital

Beijing, China

RECRUITING

Study Officials

• Hui Zhao, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xizhao Sui, MD

CONTACT

eastlifer@sina.com

Hui Zhao, MD

CONTACT

zhaohui@pukph.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pro

Study Record Dates

• First Submitted: September 17, 2016
• First Posted: September 21, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: September 21, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)