Forceps Versus Cryobiopsy in Undiagnosed Exudative Pleural Effusion Using Rigid Thoracoscopy

NCT07869056 | Completed

• 1 other identifier: MD 12-10-2022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

This study compared two ways of taking tissue samples from the lining of the lung (pleura) during rigid thoracoscopy in adults with pleural effusion of unknown cause: conventional forceps biopsy and cryobiopsy (freezing the tissue so a larger sample can be taken). Both methods were used in the same patients during the same procedure. The study looked at how often each method gave a diagnosis, the size and quality of the samples, and side effects such as bleeding and pain.

Conditions

Pleural Effusion; Exudative Pleural Effusion; Mesothelioma

Keywords

Cryobiopsy; Forceps Biopsy; Rigid Thoracoscopy; Medical Thoracoscopy; Pleural Biopsy; Undiagnosed Pleural Effusion

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield

  Proportion of patients in whom the biopsy specimen gave a definitive histopathological diagnosis, assessed separately for cryobiopsy and forceps biopsy.

  Periprocedural

Secondary Outcomes (5)

• Preservation of cellular architecture

  Periprocedural

• Crush artifact

  Periprocedural

• Mild bleeding

  Periprocedural

• Procedural pain

  Periprocedural

• Biopsy specimen size

  Periprocedural

Study Arms (1)

Paired Biopsy

EXPERIMENTAL

All patients underwent rigid thoracoscopy with four forceps biopsies and four cryobiopsies in the same session. Each patient served as his or her own control.

Procedure: Pleural Cryobiopsy; Procedure: Pleural Forceps Biopsy

Interventions

Pleural Cryobiopsy PROCEDURE

Four cryobiopsies were taken from the pleura during rigid thoracoscopy using a flexible cryoprobe (ERBOKRYO CA, CO2 gas, freezing time 30 seconds).

Paired Biopsy

Pleural Forceps Biopsy PROCEDURE

Four conventional forceps biopsies were taken from the pleura during the same rigid thoracoscopy session.

Paired Biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years.
• Undiagnosed exudative pleural effusion.
• No contraindications for thoracoscopy.

You may not qualify if:

• Diagnosed pleural effusion.
• Absolute or relative contraindications for thoracoscopy (coagulation disorders, thrombocytopenia, hemodynamic instability, arrhythmias).
• Uncorrected hypoxemia despite oxygen administration, or oxygen saturation less than 90%.
• Patients who refuse the procedure.
• Small pleural space.

Sponsors & Collaborators

• Ahmed Zakaria Elsaeed: lead
• Benha University: collaborator

Study Sites (2)

Kafrelsheikh University Hospitals

Sakhā, Kafr el-Sheikh Governorate, Egypt

Location

benha University Hospitals

Al Qalyubiyah, Qalyubia Governorate, Egypt

Location

MeSH Terms

Conditions

Pleural Effusion; Mesothelioma

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial

Study Officials

• Mohamed Elmahdy

  Benha University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Chest Diseases

Model Details: Paired within-patient comparison. Each patient underwent both forceps biopsy and cryobiopsy during the same rigid thoracoscopy session, and each patient served as his or her own control.

Study Record Dates

• First Submitted: October 1, 2026
• First Posted: October 9, 2026
• Study Start: September 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)