NCT03828903

Brief Summary

The purpose of this study is to evaluate the feasibility, size and quality of the specimens obtained by cryoprobe in comparison to those specimens obtained by flexible forceps during medical thoracoscopy in diagnosis of pleural effusion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 4, 2019

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 10, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2021

Completed
Last Updated

December 9, 2021

Status Verified

October 1, 2021

Enrollment Period

1.5 years

First QC Date

January 26, 2019

Last Update Submit

November 26, 2021

Conditions

Pleural Effusion

Keywords

Cryobiopsy

Outcome Measures

Primary Outcomes (1)

  • comparison between pleural biopsy specimens obtained by flexible forceps with those obtained with cryoprobe during medical thoracoscopy in diagnosis of pleural effusion.

    1\_size of pleural biopsy obtained by cryoprobe in comparison to those obtained by flexible forceps (in millimeter).

    12 months

Secondary Outcomes (3)

  • Complication assessment

    12 months

  • assessment pleural fluid

    12 months

  • assessment of post procedure pain

    12 months

Study Arms (1)

pleural effusion patients

EXPERIMENTAL

medical thoracoscopy will e performed to patients with pleural effusion and pleural biopsy by forceps ad cryoprobe will be obtained

Device: Cryoprobe

Interventions

CryoprobeDEVICE

* The probe (ERBE Elektromedizin GmbH; Tubingen, Germany of 2.4mm) will be placed perpendicular to the surface of the parietal pleura with the tip of the probe extended well beyond the tip of the scope using the marking on the probe and with direct visualization. * The tip of the cryoprobe will be attached to suspicious part of parietal pleura . * The frozen tissue is going to be extracted by gently pulling of the probe. * Freezing will be carried out for 6 to 10 seconds depending on the visual assessment of pleural texture. * The probe with the attached biopsy sample is going to be removed together with the thoracoscope through trocar. * The biopsy sample will be released from the probe by thawing in the saline. * The semirigid pleuroscope will be reintroduced through the port and the pleura will be revisualized for bleeding.

pleural effusion patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 1. Unilateral moderate or massive exudative pleural effusion patients. 2. Undiagnosed pleural effusion after simple pleural fluid aspiration, cytology or blind (closed) pleural biopsy using Abram's needle.
  • \. Age\>18 years old

You may not qualify if:

  • Transudative pleural effusion.
  • Exudative pleural effusion less than one third of hemithorax.
  • Presence of hemorrhagic diathesis (prothrombin concentration \<50% and platelet count \<80,000/mm 3).
  • Poor performance state (ECOG performance status \>4) as recommended in BTS (British thoracic society) guidelines 2010.
  • Sever uncontrollable cough, hypercapnia and sever respiratory distress.
  • Fibrothorax, excessive pleural adhesion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Assuit University hospital

Asyut, 71511, Egypt

Location

Alaa Salah Abdel gany

Asyut, Egypt

Location

Related Publications (2)

  • Chen CH, Cheng WC, Wu BR, Chen CY, Chen WC, Liao WC, Tu CY. Feasibility and Safety of Pleuroscopic Cryobiopsy of the Pleura: A Prospective Study. Can Respir J. 2018 Jan 22;2018:6746470. doi: 10.1155/2018/6746470. eCollection 2018.

    PMID: 29610630BACKGROUND

  • Tousheed SZ, Manjunath PH, Chandrasekar S, Murali Mohan BV, Kumar H, Hibare KR, Ramanjaneya R. Cryobiopsy of the Pleura: An Improved Diagnostic Tool. J Bronchology Interv Pulmonol. 2018 Jan;25(1):37-41. doi: 10.1097/LBR.0000000000000444.

    PMID: 29261578BACKGROUND

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Study Officials

  • Reham M El morshedy, Lecturer

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer, Chest Department and tuberculosis

Study Record Dates

First Submitted

January 26, 2019

First Posted

February 4, 2019

Study Start

March 10, 2020

Primary Completion

September 10, 2021

Study Completion

October 10, 2021

Last Updated

December 9, 2021

Record last verified: 2021-10

Locations

EG(2)