NCT06964308

Brief Summary

This study aims to evaluate the diagnostic efficacy, safety, and clinical outcomes of thoracoscopic pleural biopsy in the management of pleural diseases.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

October 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 9, 2025

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

May 9, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

March 16, 2025

Last Update Submit

April 30, 2025

Conditions

Pleural Diseases

Outcome Measures

Primary Outcomes (1)

  • early postoperative follow up for thoracoscopic pleural biopsy in the management of pleural diseases.

    return to daily activity

    3 days after procedure

Study Arms (1)

Thoracoscopic pleural biopsy

OTHER

This arm aims to evaluate the diagnostic efficacy, safety, and clinical outcomes of thoracoscopic pleural biopsy in the management of pleural diseases.

Procedure: thoracoscopic pleural biopsy.

Interventions

thoracoscopic pleural biopsy.PROCEDURE

This intervention aims to evaluate the diagnostic efficacy, safety, and clinical outcomes of thoracoscopic pleural biopsy in the management of pleural diseases.

Thoracoscopic pleural biopsy

Eligibility Criteria

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

You may qualify if:

  • Patients with suspected pleural disease who have been referred for thoracoscopic pleural biopsy
  • Age: Adults aged 18 years and older
  • Patients should have undergone necessary preoperative evaluations, including imaging studies (e.g., chest X-ray, CT scan) that indicate a need for biopsy.

You may not qualify if:

  • Contraindications to Thoracoscopic Biopsy: Patients with contraindications to thoracoscopic biopsy
  • Infeasibility of Procedure: Patients with anatomical or physiological factors that make thoracoscopic biopsy technically unfeasible or unsafe (e.g., severe pleural adhesions or distorted anatomy).
  • Alternative Diagnoses: Patients who have been definitively diagnosed with a condition that does not require thoracoscopic biopsy for further evaluation.
  • Pregnancy: Pregnant women may be excluded due to potential risks to the fetus and the need for specific procedural considerations.
  • Inability to Provide Consent: Patients who are unable to provide informed consent due to cognitive impairment, language barriers, or other reasons.
  • Participation in Concurrent Studies: Patients currently participating in other clinical studies that could interfere with the outcomes of this study or affect their eligibility.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

Related Publications (3)

  • Solari E, Marcozzi C, Ottaviani C, Negrini D, Moriondo A. Draining the Pleural Space: Lymphatic Vessels Facing the Most Challenging Task. Biology (Basel). 2022 Mar 10;11(3):419. doi: 10.3390/biology11030419.

    PMID: 35336793BACKGROUND

  • Yao X, Abd Hamid M, Sundaralingam A, Evans A, Karthikappallil R, Dong T, Rahman NM, Kanellakis NI. Clinical perspective and practices on pleural effusions in chronic systemic inflammatory diseases. Breathe (Sheff). 2020 Dec;16(4):200203. doi: 10.1183/20734735.0203-2020.

    PMID: 33447289BACKGROUND

  • Shaikh F, Lentz RJ, Feller-Kopman D, Maldonado F. Medical thoracoscopy in the diagnosis of pleural disease: a guide for the clinician. Expert Rev Respir Med. 2020 Oct;14(10):987-1000. doi: 10.1080/17476348.2020.1788940. Epub 2020 Jul 12.

    PMID: 32588676BACKGROUND

MeSH Terms

Conditions

Pleural Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Central Study Contacts

Ahmed O Yehya, Resident

CONTACT

01146628670ahmedosamayehya37@yahoo.com

essam A mokhtar, Professor

CONTACT

01011908152

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
Resident, Department of cardiothoracic Surgery, Faculty of Medicine, Sohag University

Study Record Dates

First Submitted

March 16, 2025

First Posted

May 9, 2025

Study Start

October 1, 2024

Primary Completion

May 30, 2025

Study Completion

May 30, 2025

Last Updated

May 9, 2025

Record last verified: 2025-03

Locations

EG(1)