---
title: Efficacy And Safety Of Thoracoscopic Cryobiopsy In Patients With Undiagnosed Exudative Pleural Effusion
nct_id: NCT04761003
overall_status: COMPLETED
phase: NA
sponsor: Mansoura University
study_type: INTERVENTIONAL
primary_condition: Pleura; Exudate
countries: Egypt
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04761003.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04761003"
ct_last_update_post_date: 2021-03-15
last_seen_at: "2026-05-12T07:02:10.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Efficacy And Safety Of Thoracoscopic Cryobiopsy In Patients With Undiagnosed Exudative Pleural Effusion

**NCT ID:** [NCT04761003](https://clinicaltrials.gov/study/NCT04761003)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 50
- **Lead Sponsor:** Mansoura University
- **Conditions:** Pleura; Exudate
- **Start Date:** 2021-01-01
- **Completion Date:** 2021-03-01
- **CT.gov Last Update:** 2021-03-15

## Brief Summary

To demonstrated the efficacy and safety of taking biopsy specimens from parietal pleura in undiagnosed exudative pleural effusion

## Detailed Description

Pleural effusions are either transudate or exudate according to the biochemical analysis of aspirated pleural fluid. Thoracentesis or blind pleural biopsy may not provide a definitive diagnosis. Cryobiopsy has more successful diagnostic results than forceps biopsies with complications (only hemorrhage) during procedures. Cryobiopsy can obtain more diagnostic biopsies due to the size of the biopsies and best property in expressions of an artifact-free sample area

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* patients diagnosed as exudative pleural effusion according to Light criteria .informed written consents were taken from all patients enrolled in the study

Exclusion Criteria:

* patients who refused participation ,patients unfit for medical thoracoscopy (MT) will be excluded from the study such as:Uncooperative patient ,Severe uncorrected hypoxemia in spite of continuous oxygen administration, because it's necessary to keep oxygen saturation above 90 % during procedure ,patients who could not tolerate the lateral decubitus position for a period long adequate to do the thoracoscopy, unstable cardiovascular or hemodynamic condition, uncorrected Coagulation defects and small pleural space
```

## Arms

- **Group I (Cryobiopsy group):** (ACTIVE_COMPARATOR) — patients where patients will be subjected to thoracoscopic cryobiopsy.
- **Group II (Forceps group)** (ACTIVE_COMPARATOR) — patients where patients will be subjected to thoracoscopic forceps biopsy.

## Interventions

- **Thoracoscopy forceps** (DEVICE) — take pleural biopsy

## Primary Outcomes

- **efficacy which determined by the diagnostic yield** _(time frame: baseline)_ — comparing forceps biopsy and cryobiopsy as regard: efficacy which determined by the diagnostic yield.
- **efficacy which determined by the size of biopsy** _(time frame: baseline)_ — comparing forceps biopsy and cryobiopsy as regard: efficacy which determined by the size of biopsy.
- **The incidence of complications** _(time frame: baseline)_ — comparing forceps biopsy and cryobiopsy as regard: Safety which determined by the incidence of complications

## Locations (1)

- Mansoura University, Al Mansurah, Egypt

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.mansoura university|al mansurah||egypt` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04761003.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04761003*  
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