Transbronchial Ablation for Peripheral Lung Tumor

NCT ID: NCT02972177

Last Updated: 2020-02-18

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

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-07

Study Completion Date

2021-12-31

Brief Summary

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The objective of the study was to evaluate the efficacy and safety of navigation bronchoscopy guided transbronchial ablation for the treatment of inoperable peripheral lung tumor.

Detailed Description

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The study is aimed to evaluate the efficacy and safety of navigation bronchoscopy guided transbronchial ablation for treating inoperable malignant lung tumor. The study is designed as a single-center prospective trial. The participating centers are Department of pulmonary medicine and endoscopy, Shanghai Chest Hospital,Shanghai Jiao Tong University, China. Patients are divided into two groups, including radiofrequency ablation group and microwave ablation group. Sixty patients are expected to be enrolled into the study with 30 patients in each group.

Conditions

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Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radiofrequency ablation group

Patients with inoperable peripheral lung tumor will be performed transbronchial radiofrequency ablation with the guidance of navigation bronchoscopy. Post treatment response will be evaluated and follow up will be carried out according to the standard procedure.

Group Type EXPERIMENTAL

Radiofrequency ablation

Intervention Type PROCEDURE

Transbronchial radiofrequency ablation will be performed under the guidance of navigation bronchoscopy.

Microwave ablation group

Patients with inoperable peripheral lung tumor will be performed transbronchial microwave ablation with the guidance of navigation bronchoscopy. Post treatment response will be evaluated and follow up will be carried out according to the standard procedure.

Group Type EXPERIMENTAL

Microwave ablation

Intervention Type PROCEDURE

Transbronchial microwave ablation will be performed under the guidance of navigation bronchoscopy.

Interventions

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Radiofrequency ablation

Transbronchial radiofrequency ablation will be performed under the guidance of navigation bronchoscopy.

Intervention Type PROCEDURE

Microwave ablation

Transbronchial microwave ablation will be performed under the guidance of navigation bronchoscopy.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patients older than 18 year-old.
2. Patients meeting one of the following criteria: 1) patients discovered with peripheral lung lesions that have demonstrated to be lung cancer by pathology with the clinical stage no later than IIA. 2) recurrent or progressive single lesion or solitary intrapulmonary metastasis after surgery, radiotherapy, chemotherapy or other treatment.3) multiple primary lung cancer with the number of tumors no more than 5 and no metastasis. 4) pulmonary metastases with effective treatment of primary disease, the number of metastases no more than 5 and no other metastasis.
3. Chest CT shows the length-diameter of the tumor is more than 8mm and no more than 50mm.
4. Patients are unsuitable for surgery assessed by multidisciplinary team and agree to the primary treatment of ablation.
5. Patients have good compliance and sign the informed consent.

Exclusion Criteria

1. Patients cannot receive bronchoscopy for the severe cardiopulmonary dysfunction and other indications.
2. Patients have contraindications of general anesthesia.
3. Chest CT or bronchoscopy shows that guided and treatment instruments cannot reach the peripheral lung lesion.
4. There are large blood vessels or important structures adjacent to peripheral lung lesion.
5. Researchers consider the patient do not fit for the study due to other reasons.
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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Jiayuan Sun

Director, Department of Endoscopy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jiayuan Sun, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Chest Hospital

Locations

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Shanghai Chest Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiayuan Sun, MD,PhD

Role: CONTACT

86-021-22200000-1521

Facility Contacts

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Jiayuan Sun, MD,PhD

Role: primary

18017321598

References

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Harris K, Puchalski J, Sterman D. Recent Advances in Bronchoscopic Treatment of Peripheral Lung Cancers. Chest. 2017 Mar;151(3):674-685. doi: 10.1016/j.chest.2016.05.025. Epub 2016 Jun 10.

Reference Type BACKGROUND
PMID: 27292045 (View on PubMed)

Koizumi T, Tsushima K, Tanabe T, Agatsuma T, Yokoyama T, Ito M, Kanda S, Kobayashi T, Yasuo M. Bronchoscopy-Guided Cooled Radiofrequency Ablation as a Novel Intervention Therapy for Peripheral Lung Cancer. Respiration. 2015;90(1):47-55. doi: 10.1159/000430825. Epub 2015 May 30.

Reference Type BACKGROUND
PMID: 26044954 (View on PubMed)

Jahangeer S, Forde P, Soden D, Hinchion J. Review of current thermal ablation treatment for lung cancer and the potential of electrochemotherapy as a means for treatment of lung tumours. Cancer Treat Rev. 2013 Dec;39(8):862-71. doi: 10.1016/j.ctrv.2013.03.007. Epub 2013 Apr 17.

Reference Type BACKGROUND
PMID: 23601905 (View on PubMed)

Wasser EJ, Dupuy DE. Microwave ablation in the treatment of primary lung tumors. Semin Respir Crit Care Med. 2008 Aug;29(4):384-94. doi: 10.1055/s-2008-1081281.

Reference Type BACKGROUND
PMID: 18651356 (View on PubMed)

Fernando HC, De Hoyos A, Landreneau RJ, Gilbert S, Gooding WE, Buenaventura PO, Christie NA, Belani C, Luketich JD. Radiofrequency ablation for the treatment of non-small cell lung cancer in marginal surgical candidates. J Thorac Cardiovasc Surg. 2005 Mar;129(3):639-44. doi: 10.1016/j.jtcvs.2004.10.019.

Reference Type BACKGROUND
PMID: 15746749 (View on PubMed)

Dupuy DE, Fernando HC, Hillman S, Ng T, Tan AD, Sharma A, Rilling WS, Hong K, Putnam JB. Radiofrequency ablation of stage IA non-small cell lung cancer in medically inoperable patients: Results from the American College of Surgeons Oncology Group Z4033 (Alliance) trial. Cancer. 2015 Oct 1;121(19):3491-8. doi: 10.1002/cncr.29507. Epub 2015 Jun 19.

Reference Type BACKGROUND
PMID: 26096694 (View on PubMed)

Ye X, Fan W, Chen JH, Feng WJ, Gu SZ, Han Y, Huang GH, Lei GY, Li XG, Li YL, Li ZJ, Lin ZY, Liu BD, Liu Y, Peng ZM, Wang H, Yang WW, Yang X, Zhai B, Zhang J. Chinese expert consensus workshop report: Guidelines for thermal ablation of primary and metastatic lung tumors. Thorac Cancer. 2015 Jan;6(1):112-21. doi: 10.1111/1759-7714.12152. Epub 2015 Jan 7.

Reference Type BACKGROUND
PMID: 26273346 (View on PubMed)

Xie F, Chen J, Jiang Y, Sun J, Hogarth DK, Herth FJF. Microwave ablation via a flexible catheter for the treatment of nonsurgical peripheral lung cancer: A pilot study. Thorac Cancer. 2022 Apr;13(7):1014-1020. doi: 10.1111/1759-7714.14351. Epub 2022 Feb 14.

Reference Type DERIVED
PMID: 35166043 (View on PubMed)

Other Identifiers

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SHCHE201603

Identifier Type: -

Identifier Source: org_study_id

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