Optimization of the Sensitivity of Histological Diagnosis of Pulmonary Nodules (CRYOPROBE)

February 13, 2024 updated by: Elsan

Optimization of the Sensitivity of Histological Diagnosis of Pulmonary Nodules Using Cryoprobes Versus Standard Biopsy Forceps During Distal Sampling Guided by Mini Radial Ultrasound Probes

In pulmonary oncology, the diagnosis of medium-sized pulmonary nodules (10 to 20 mm), too distal to be reached by standard bronchial fibroscopy but remaining proximal, is difficult.

There are 2 techniques: transthoracic puncture-biopsy under CT scan, usually performed by radiologists, and distal sampling guided by radial ultrasound mini-probe.

The limitations of the last technique could be overcome by the use of cryoprobes for sampling, as they would take more tissue by freezing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Concerning the interventional pneumology technique, it is performed in two steps: identification of the mass with the mini ultrasound probe and then distal sampling with a small biopsy forceps. Experience shows that there is a significant difference between the identification of the mass, which is fairly conclusive, and the samples, which are much less productive (60% at best), because it is necessary that :

  • that the tumor is endo-bronchial,
  • that the forceps open sufficiently to take samples by back and forth movements
  • but, on the other hand, that the bronchus is not too wide.

The use of cryoprobes would allow to take more tissue by freezing. The target tissue freezes at the tip of the cryoprobe and can be detached by traction. The longer the freezing time, the more tissue is removed.

Various studies of endo-bronchial visible tumor diagnosis have compared these 2 sampling techniques (cryoprobe and conventional biopsy forceps). The cryoextraction technique performed by cryoprobes has a superior diagnostic yield (compared to flexible forceps biopsy) due to large biopsies and superior quality of the biopsied tissue (very few crush artifacts or hematomas; the morphological structure remains intact).

In this context, it seems interesting to compare these 2 techniques but in distal situation, under ultrasound detection with the mini-probes, for tumors not visible in endo-bronchial. The first samples taken in the investigating center by this technique are convincing.

In the framework of this study, in the same operating time and after ultrasound identification of the tumor, biopsies will be performed by conventional forceps (5 samples) and by cryoprobes (3 samples) on the same site. The sequence of use of one or the other technique will be randomly selected. Thus, each patient is his own control.

This first pilot study will explore the feasibility, effectiveness and safety of this procedure. Depending on the results of this comparative study, a second study including more patients will validate this procedure.

Study Type

Interventional

Enrollment (Actual)

14

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

  • France
      • Saint-Herblain, France, 44800
        • Pneumologie Elsan Santé Atlantique

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

Description

Inclusion Criteria:

  • Patient with a tumor of any location with a draining bronchus (primary lung cancer or lung metastases)
  • Suspected lung nodule(s) with anatomical situation on mid 1/3 CT
  • Presence of at least one lung nodule of sufficient size on CT to allow for at least 8 tissue samples
  • Male or female aged ≥ 18 years
  • Mandatory membership in a health insurance plan
  • Patient who has been informed about the study and has signed the informed consent form

Exclusion Criteria:

  • Proximal or distal pulmonary nodule(s)
  • Pacemaker patient
  • Pregnant or nursing women
  • Patients under legal protection

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cryoprobes First
Use of cryoprobes and then conventional forceps during the same operating time.
Device: Cryoprobes First
In this experimental group, the Cryoprobe is used in first and the classic biopsy forceps in a second time. This medical device under study is the flexible, single-use Cryoprobe, supplied in sterile condition, 1.1 mm in diameter, 1150 mm long, with extraction tube, 817 mm long (reference 20402-401), or 757 mm long (reference 20402-402) marketed. These cryoprobes are covered by a CE marking. Cryoprobes must be used in conjunction with the Erbecryo®2 device and its accessories.
Experimental: Cryoprobes Second
Use of conventional forceps and then cryoprobes during the same operating time.
Device: Cryoprobes Second
In this second experimental group, the same medical devices are used but in the other order.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validity of samples by cryoprobes
Time Frame: Within 24 hours after intervention
Histological diagnosis from the material collected by cryoprobes and conventional forceps
Within 24 hours after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity, sensitivity, and predictive values of each technique
Time Frame: Within 24 hours after intervention
specificity, sensitivity, predictive values
Within 24 hours after intervention
Tolerance and safety of the samples taken
Time Frame: 15 Days after intervention
Collection of adverse events for the duration of the study.
15 Days after intervention

Collaborators and Investigators

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

Sponsor

Elsan

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)

November 5, 2022

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

September 24, 2021

First Submitted That Met QC Criteria

January 28, 2022

First Posted (Actual)

February 9, 2022

Study Record Updates

Last Update Posted (Estimated)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRYOPROBE
  • 2021-A01209-32 (Other Identifier: ANSM)

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.

Clinical Trials on Nodule

Clinical Trials on Cryoprobes First

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe