Evaluation of Clinical Significance and Feasibility of CT Guided Biopsy of Double Site Lesions：A Preliminary Lung Centered Study

July 2, 2021 updated by: Peking University Third Hospital
This study aims to explore the clinical significance and feasibility of double site biopsy by analyzing the pathological characteristics and the incidence of main complications of CT guided puncture biopsy of lung and other parts coexisting lesions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

CT guided biopsy is minimally invasive, accurate and low cost. It is often used as an important diagnostic method when the clinical suspect of malignant disease or the treatment effect of the disease is not good. In patients with suspected malignant lung disease, metastasis of other parts of lung, pulmonary door, mediastinum, bone, and distant soft tissue may be combined at the same time. It is the key link of clinical work to evaluate the nature of these coexisting lesions accurately and choose appropriate treatment methods. At present, there is little clinical study on lung centered double site biopsy. This study aims to explore the clinical significance and feasibility of double site biopsy by analyzing the pathological characteristics and the incidence of main complications of CT guided puncture biopsy of lung and other parts coexisting lesions.

Study Type

Observational

Enrollment (Actual)

134

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
    • Beijing
      • Beijing, Beijing, China, 010
        • Peking University Third 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Clinical data of 134 consecutive patients with suspected malignancy who underwent dual site CT guided biopsy in the Third Hospital of Peking University from January 2011 to October 2014

Description

Inclusion Criteria:

  • patients with suspected malignancy
  • underwent dual site CT guided biopsy in the Third Hospital of Peking University

Exclusion Criteria:

-

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Clinical diagnosis of suspected malignant tumor by dual site CT guided needle biopsy
Diagnostic test: Double site CT guided needle biopsy
Double site CT guided needle biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
for the combination of two site biopsies
Time Frame: up to 2weeks
The incidence of 4 kinds of combined pathological results in different lesion location groups was analyzed.
up to 2weeks
for the combination of two site biopsy approaches 1
Time Frame: up to 2weeks
The incidence of pneumothorax on the surgical side after unilateral lung biopsy
up to 2weeks
for the combination of two site biopsy approaches 2
Time Frame: up to 2weeks
the incidence of pneumothorax on the surgical side after bilateral lung biopsy
up to 2weeks
for the combination of two site biopsy approaches 3
Time Frame: up to 2weeks
the incidence of intra tissue hemorrhage after biopsy were statistically analyzed.
up to 2weeks

Collaborators and Investigators

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

Sponsor

Peking University Third Hospital

Investigators

  • Principal Investigator: Huishu Huishu, Peking University Third Hospital

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)

March 1, 2018

Primary Completion (Actual)

April 30, 2018

Study Completion (Actual)

May 31, 2018

Study Registration Dates

First Submitted

June 29, 2021

First Submitted That Met QC Criteria

July 2, 2021

First Posted (Actual)

July 14, 2021

Study Record Updates

Last Update Posted (Actual)

July 14, 2021

Last Update Submitted That Met QC Criteria

July 2, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M2018060

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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