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

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ClinicalTrials.gov Identifier: NCT02908646
Recruitment Status : Unknown
Verified September 2016 by Jun Wang, Peking University People's Hospital.
Recruitment status was:  Recruiting
First Posted : September 21, 2016
Last Update Posted : September 21, 2016
Sponsor:
Information provided by (Responsible Party):
Jun Wang, 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

Condition or disease Intervention/treatment Phase
Thoracic Surgery Procedure: microcoil localization Procedure: hookwire localization Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : July 2017

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




Primary Outcome Measures :
  1. complications after CT-guided localization [ Time Frame: 1 years ]
    any complication occured after CT-guided localization


Secondary Outcome Measures :
  1. major complications after CT-guided localization [ Time Frame: 1 years ]
    major complication refers to complication that need to be interfered before surgery

  2. success of the intervention of localization [ Time Frame: 1 year ]
    success of the intervention of CT guided localization by microcoil or hookwire

  3. success of the localization by thoracoscopic surgery [ Time Frame: 1 year ]
    success of the localization by thoracoscopic surgery under the guide of the planted microcoil or hookwire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02908646


Contacts
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Contact: Xizhao Sui, MD eastlifer@sina.com
Contact: Hui Zhao, MD zhaohui@pukph.edu.cn

Locations
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China
Peking university people's hospital Recruiting
Beijing, China
Contact: Jun Wang, MD         
Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Principal Investigator: Hui Zhao, MD Department of Thoracic Surgery, Center for Mini-invasive Thoracic Surgery, People's Hospital, Peking University
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Responsible Party: Jun Wang, Pro, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT02908646    
Other Study ID Numbers: 2014PHB113
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: September 21, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plan to make individual participant data (IPD) available