Intraoperative Ultrasonographic Localization of Pulmonary Nodules in VATS

• Conditions: Ultrasonography

• Registration Number: NCT03599505
• Lead Sponsor: Shanghai Chest Hospital

Brief Summary

This study is conducted to explore the feasibility and value of Intraoperative ultrasonographic localization of pulmonary nodules in video-assisted thoracoscopic surgery (VATS).

Detailed Description

The study is designed as a single center prospective trial. The participating center is Department of Ultrasound, Shanghai Chest Hospital, Shanghai Jiao Tong University, China. The study is expected to enroll 200 patients. The feasibility and value of Intraoperative ultrasonographic localization of pulmonary nodules in VATS will be explored. The accuracy rate of localization will be evaluated using gray scale mode and elastography mode. Intraoperative ultrasonographic localization will be performed using an ultrasound system (HI VISON Ascendus), which is equipped with a 5-10MHz mechanical probe (EUP-OL531).

Study Timeline

• Study First Submitted: 2018-06-21
• Status Verified: 2018-07
• Study Start: 2018-07
• Primary Completion: 2018-07
• Study First Submitted QC: 2018-07-23
• Last Update Submitted: 2018-07-23
• Study First Posted: 2018-07-26
• Last Update Posted: 2018-07-26
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Patients who are older than 18 year-old.
2. Chest CT shows pulmonary nodule suspected to be malignant that need to undergo VATS.
3. Patients who have good compliance and sign informed consent.

Exclusion Criteria

1. Patient with severe asthma and pulmonary fibrosis.
2. Refusal of participation.
3. Severe cardiopulmonary dysfunction and other indications that can't receive VATS.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The accuracy rate of localization	one year	The accuracy rate of localization will be evaluated using gray scale mode and elastography mode using pathology as a reference.

Secondary Outcome Measures

Name	Time	Method
Correlation of distance between the lesion and pleura and localization	one year	Whether distance between the lesion and pleura affects localization will be explored.
Time of localization	one week	The time of intraoperative ultrasonographic localization will be recorded.
Correlation of lesion size and localization	one year	Whether lesion size affects localization will be explored in the study.