Transbronchial Ablation for Peripheral Lung Tumor

February 16, 2020 updated by: Jiayuan Sun, Shanghai Chest Hospital

Clinical Study of Navigation Bronchoscopy Guided Ablation for the Treatment of Peripheral Lung Tumor

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200030
        • Recruiting
        • Shanghai Chest Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Procedure: Radiofrequency ablation
Transbronchial radiofrequency ablation will be performed under the guidance of navigation bronchoscopy.
EXPERIMENTAL: 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.
Procedure: Microwave ablation
Transbronchial microwave ablation will be performed under the guidance of navigation bronchoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local control rate
Time Frame: Three months after ablation
Local control rate was defined as the proportion of the complete ablation and incomplete ablation of the tumor.
Three months after ablation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: From the time of treatment to the time of disease progression or death, assessed up to 1 year
PFS was defined from the first day after ablation to progression of target lesions and/or appearance of new lesions or death.
From the time of treatment to the time of disease progression or death, assessed up to 1 year
Overall survival（OS）
Time Frame: From the time of treatment to the time of the patient death, assessed up to 3 years
Overall survival（OS) is evaluated after the treatment of ablation until the patient death.
From the time of treatment to the time of the patient death, assessed up to 3 years
Cancer-specific survival
Time Frame: From the time of treatment to the time of the patient death, assessed up to 3 years
The cause of death is related to the patient's underlying malignancy.
From the time of treatment to the time of the patient death, assessed up to 3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE 4.0
Time Frame: From the time of treatment to the complication occured, assessed up to 1 month
Complications refer to serious operation-related adverse events during and after the operation,such as pneumothorax, bleeding and infection.
From the time of treatment to the complication occured, assessed up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Chest Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 7, 2018

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

November 12, 2016

First Submitted That Met QC Criteria

November 21, 2016

First Posted (ESTIMATE)

November 23, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 18, 2020

Last Update Submitted That Met QC Criteria

February 16, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHCHE201603

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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