Intraoperative Ultrasonographic Localization of Pulmonary Nodules in VATS

NCT ID: NCT03599505

Last Updated: 2018-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-31

Study Completion Date

2019-12-31

Brief Summary

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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

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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).

Conditions

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Ultrasonography

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Chest Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xu Lei

Chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lei Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Chest Hospital

Central Contacts

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Lei Wang, MD

Role: CONTACT

86-021-22200000 ext. 1416

References

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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.

Reference Type BACKGROUND
PMID: 19660350 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15680811 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20103238 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17318707 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17494801 (View on PubMed)

Other Identifiers

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Chest008

Identifier Type: -

Identifier Source: org_study_id

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