Pleural EffusionNCT07869056
Forceps Versus Cryobiopsy in Undiagnosed Exudative Pleural Effusion Using Rigid Thoracoscopy
A study testing Pleural Cryobiopsy and Pleural Forceps Biopsy in people with Pleural Effusion and Exudative Pleural Effusion, run by Ahmed Zakaria Elsaeed at 2 sites in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion, Exudative Pleural Effusion, Mesothelioma
- What is being tested?
- Pleural Cryobiopsy and Pleural Forceps Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Sep 2022to 1 Sep 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years.
- Undiagnosed exudative pleural effusion.
- No contraindications for thoracoscopy.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
benha University Hospitals
Al Qalyubiyah, Qalyubia Governorate
Kafrelsheikh University Hospitals
Sakhā, Kafr el-Sheikh Governorate
About this study
Official title: Comparative Study Between Forceps and Cryobiopsies in Undiagnosed Exudative Pleural Effusion Using Rigid Thoracoscopy
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.
Read the detailed description
Undiagnosed exudative pleural effusion is a common diagnostic problem. Medical thoracoscopy is the gold standard for diagnosis, but its accuracy depends on the quality of the pleural biopsy. Forceps biopsy usually gives small samples with crush artifact, while cryobiopsy may give larger, better-preserved samples.
This was a prospective paired comparative study in the Chest Departments of Benha University Hospitals and Kafrelsheikh University Hospitals (September 2022 to September 2024). Forty adult patients with undiagnosed exudative pleural effusion underwent rigid thoracoscopy under local anesthesia with lidocaine and Patients received intravenous pethidine. In each patient, four forceps biopsies and four cryobiopsies were taken during the same session, according to a predefined protocol. Cryobiopsies were taken with an ERBOKRYO CA device using CO2, with a freezing time of 30 seconds. Specimens were sent separately to the same pathologist. Pain and bleeding were assessed during the procedure.
Written informed consent was obtained from all participants.The study was approved from the Research Ethics Committee, Faculty of Medicine, Benha University (code MD 12-10-2022) and final approval (approval number SCCREIRB-MEDICINEBENHAUNI-GU-001-020626-011).
Retrospective registration: this study was completed before it was registered on ClinicalTrials.gov.
- Conditions
- Pleural Effusion, Exudative Pleural Effusion, Mesothelioma
- Being tested
- Pleural Cryobiopsy, Pleural Forceps Biopsy
- Keywords
- Cryobiopsy, Forceps Biopsy, Rigid Thoracoscopy, Medical Thoracoscopy, Pleural Biopsy, Undiagnosed Pleural Effusion
- Medical subject headings
- Pleural Effusion, Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pleural CryobiopsyProcedure or surgery
Four cryobiopsies were taken from the pleura during rigid thoracoscopy using a flexible cryoprobe (ERBOKRYO CA, CO2 gas, freezing time 30 seconds).
Pleural Forceps BiopsyProcedure or surgery
Four conventional forceps biopsies were taken from the pleura during the same rigid thoracoscopy session.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Pleural Cryobiopsy; Procedure: Pleural Forceps Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield
Proportion of patients in whom the biopsy specimen gave a definitive histopathological diagnosis, assessed separately for cryobiopsy and forceps biopsy.
Measured: Periprocedural
Secondary outcomes (5)
Preservation of cellular architecture
Proportion of specimens with preserved cellular architecture on histology, per technique. Not specified in the original protocol; assessed and reported post hoc.
Measured: Periprocedural
Crush artifact
Proportion of specimens showing crush artifact, per technique. Not specified in the original protocol; assessed and reported post hoc.
Measured: Periprocedural
Mild bleeding
Proportion of patients with mild bleeding after biopsy, per technique. Safety outcome (included in the protocol aim).
Measured: Periprocedural
Procedural pain
Proportion of patients with pain during biopsy, per technique. Safety outcome (included in the protocol aim).
Measured: Periprocedural
Biopsy specimen size
Greatest dimension (cm) of pleural biopsy specimens, per technique. Not specified in the original protocol; assessed and reported post hoc.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start1 Sep 2022
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Zakaria Elsaeed
- Sponsor type
- University, hospital or other
- Collaborators
- Benha University
- Responsible party
- Sponsor-investigator, Ahmed Zakaria Elsaeed, Kafrelsheikh University
- Investigators
- Mohamed Elmahdy, Study chair, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869056
- Sponsor's protocol ID
- MD 12-10-2022
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No