Intraoperative Ultrasonographic Localization of Pulmonary Nodules in VATS

NCT03599505 | Unknown DMC

• 1 other identifier: Chest008
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Ultrasonography

Keywords

intraoperative ultrasonographic localization; pulmonary nodules; video-assisted thoracoscopic surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Correlation of lesion size and localization

  one year

• Correlation of distance between the lesion and pleura and localization

  one year

• Time of localization

  one week

Interventions

localization group PROCEDURE

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.

Eligibility Criteria

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

Study Population

Patients older than 18 year-old with chest CT showing pulmonary nodule that need to undergo VATS will be enrolled in the study. Patient with severe cardiopulmonary dysfunction and other indications that can't receive VATS will be excluded.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Related Publications (5)

• 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.

  PMID: 19660350 BACKGROUND

• 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. doi: 10.1016/j.athoracsur.2004.07.087.

  PMID: 15680811 BACKGROUND

• 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.

  PMID: 20103238 BACKGROUND

• 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. doi: 10.1007/s00268-006-0343-7.

  PMID: 17318707 BACKGROUND

• 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. doi: 10.1378/chest.06-1017.

  PMID: 17494801 BACKGROUND

MeSH Terms

Conditions

Multiple Pulmonary Nodules

Condition Hierarchy (Ancestors)

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Lei Wang, MD

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Wang, MD

CONTACT

86-021-22200000; 13917985547@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: July 26, 2018
• Study Start: July 1, 2018
• Primary Completion: July 1, 2018
• Study Completion: December 1, 2019
• Last Updated: July 26, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share