Clinical trial NCT02908646: Comparing of Microcoil Localization and Hook Wire Localization for Resectable Pulmonary Small Nodules
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Thoracic Surgery
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: complications after CT-guided localization
timeFrame: 1 years
Secondary outcomes:
measure: major complications after CT-guided localization
timeFrame: 1 years
measure: success of the intervention of localization
timeFrame: 1 year
measure: success of the localization by thoracoscopic surgery
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking university people's hospital
Study officials:
affiliation: Department of Thoracic Surgery, Center for Mini-invasive Thoracic Surgery, People's Hospital, Peking University
name: Hui Zhao, MD
role: PRINCIPAL_INVESTIGATOR
References: