Intraoperative Ultrasonographic Localization of Pulmonary Nodules in VATS

Ultrasonography Clinical Trial

Official title:

Intraoperative Ultrasonographic Localization of Pulmonary Nodules in Video-assisted Thoracoscopic Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03599505
• Other study ID #: Chest008
• Status: Not yet recruiting
• Start date: July 2018
• Est. completion date: December 2019

Study information

• Verified date: July 2018
• Source: Shanghai Chest Hospital
• Contact: Lei Wang, MD
• Phone: 86-021-22200000
• Email: 13917985547[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2019
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Ultrasonography

Intervention

Procedure:
• localization group
Intraoperative ultrasonographic localization will be performed using an ultrasound system (HI VISON Ascendus), which is equipped with a 5-10MHz mechanical probe (EUP-OL531). The accuracy rate of localization will be evaluated using gray scale mode and elastography mode.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

References & Publications (5)

Chen W, Chen L, Yang S, Chen Z, Qian G, Zhang S, Jing J. A novel technique for localization of small pulmonary nodules. Chest. 2007 May;131(5):1526-31. — View Citation

Kondo R, Yoshida K, Hamanaka K, Hashizume M, Ushiyama T, Hyogotani A, Kurai M, Kawakami S, Fukushima M, Amano J. Intraoperative ultrasonographic localization of pulmonary ground-glass opacities. J Thorac Cardiovasc Surg. 2009 Oct;138(4):837-42. doi: 10.1016/j.jtcvs.2009.02.002. Epub 2009 Mar 26. — View Citation

Mattioli S, D'Ovidio F, Daddi N, Ferruzzi L, Pilotti V, Ruffato A, Bolzani R, Gavelli G. Transthoracic endosonography for the intraoperative localization of lung nodules. Ann Thorac Surg. 2005 Feb;79(2):443-9; discussion 443-9. — View Citation

Nakashima S, Watanabe A, Obama T, Yamada G, Takahashi H, Higami T. Need for preoperative computed tomography-guided localization in video-assisted thoracoscopic surgery pulmonary resections of metastatic pulmonary nodules. Ann Thorac Surg. 2010 Jan;89(1):212-8. doi: 10.1016/j.athoracsur.2009.09.075. — View Citation

Pittet O, Christodoulou M, Pezzetta E, Schmidt S, Schnyder P, Ris HB. Video-assisted thoracoscopic resection of a small pulmonary nodule after computed tomography-guided localization with a hook-wire system. Experience in 45 consecutive patients. World J Surg. 2007 Mar;31(3):575-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The accuracy rate of localization	The accuracy rate of localization will be evaluated using gray scale mode and elastography mode using pathology as a reference.	one year
Secondary	Correlation of lesion size and localization	Whether lesion size affects localization will be explored in the study.	one year
Secondary	Correlation of distance between the lesion and pleura and localization	Whether distance between the lesion and pleura affects localization will be explored.	one year
Secondary	Time of localization	The time of intraoperative ultrasonographic localization will be recorded.	one week