ENB-guided Ablation Therapy Combined With VATS in the Treatment of MPLC

January 28, 2021 updated by: Jiayuan Sun, Shanghai Chest Hospital

Electromagnetic Navigation Bronchoscopy Guided Ablation Therapy Combined With VATS in the Treatment of Multiple Primary Lung Cancers

The study is designed as a prospective trial whose purpose is to evaluate the effectiveness and safety of ENB-guided ablation therapy combined with VATS in the treatment of multiple primary lung cancers (MPLC).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients will be first screened, and only after meeting all the selection criteria, not meeting any exclusion criteria, and signing the informed consent, could they be enrolled in the group to receive ENB-guided ablation therapy combined with VATS. The primary endpoint is objective response rate (ORR). The secondary endpoints include progression-free survival (PFS), overall survival (OS) and safety.

Study Type

Observational

Enrollment (Anticipated)

30

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

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 minutes and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who meet inclusion/exclusion will be enrolled in the study consecutively.

Description

Inclusion Criteria:

  1. Age ≥ 18 years old.
  2. The subject is diagnosed as multiple primary lung cancer via preoperative imaging/pathological examination.
  3. Thin-slice CT images show that the ablation Lesion A is accessible/adjacent to bronchi and the size is ≤ 3 cm.
  4. The subject with multiple primary lung cancers can be treated with ENB-guided ablation therapy combined with VATS according to multidisciplinary assessment.

Exclusion Criteria:

  1. The subject who cannot tolerate general anesthesia for their cardiopulmonary function, or there are other contraindications, such as uncorrectable coagulopathy.
  2. The situation in which the investigators think that the subject is not suitable to participate in this study.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of ablation efficacy, ORR (objective response rate)
Time Frame: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 years.
ORR is defined as the proportion of patients with complete response (CR) and partial response (PR) after ablation therapy. Efficacy evaluation is based on Modifield Response Evaluation Criteria in Solid Tumors (mRECIST).
From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of ablation efficacy, PFS (progression-free survival)
Time Frame: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
PFS is defined as the time from the start of treatment to the first occurrence of disease progression or death for any cause.
From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
Evaluation of ablation efficacy, OS (overall survival)
Time Frame: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.
OS is defined as the time from the start of treatment to the death of the patient.
From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.
Observation of complications of ablation
Time Frame: From date of treatment to the one month after ablation.
Complications refer to the combination of serious adverse events related to the operation during or after the operation, mainly including pneumothorax and bleeding.
From date of treatment to the one month after ablation.

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)

July 24, 2020

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

January 24, 2021

First Submitted That Met QC Criteria

January 28, 2021

First Posted (Actual)

January 29, 2021

Study Record Updates

Last Update Posted (Actual)

January 29, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHCHE202101

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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