An interventional study of Pleural Cryobiopsy and Pleural Forceps Biopsy in Pleural Effusion, Exudative Pleural Effusion and Mesothelioma, sponsored by Ahmed Zakaria Elsaeed. Completed at 2 sites in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Ahmed Zakaria Elsaeed · Not applicable, Interventional, and Diagnostic
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.
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.
335 studies on the registry are indexed under Pleural Effusion; 63 are open to participants now.
This study's enrollment of 40 is below the median of 62 across 220 interventional studies indexed under Pleural Effusion.
Browse Pleural Effusion studies →This is the only study on the registry with Ahmed Zakaria Elsaeed as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Four cryobiopsies were taken from the pleura during rigid thoracoscopy using a flexible cryoprobe (ERBOKRYO CA, CO2 gas, freezing time 30 seconds).
Four conventional forceps biopsies were taken from the pleura during the same rigid thoracoscopy session.
Diagnostic yield
Proportion of patients in whom the biopsy specimen gave a definitive histopathological diagnosis, assessed separately for cryobiopsy and forceps biopsy.
Time frame: Periprocedural
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.
Time frame: Periprocedural
Crush artifact
Proportion of specimens showing crush artifact, per technique. Not specified in the original protocol; assessed and reported post hoc.
Time frame: Periprocedural
Mild bleeding
Proportion of patients with mild bleeding after biopsy, per technique. Safety outcome (included in the protocol aim).
Time frame: Periprocedural
Procedural pain
Proportion of patients with pain during biopsy, per technique. Safety outcome (included in the protocol aim).
Time frame: Periprocedural
Biopsy specimen size
Greatest dimension (cm) of pleural biopsy specimens, per technique. Not specified in the original protocol; assessed and reported post hoc.
Time frame: Periprocedural
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.