NCT07188714: VATs-PPE

Video-assisted Thoracoscopic Surgery (VATS) Has Revolutionised Management of Complicated PPE, Our Study to Determine VATS Decortication Technique is Needed, Compared to VATS Debridement in PPE, Also RAPID Score and Pleural US Parameters Can Predict Which VATS Procedure is Needed.

Not yet recruiting NA Last updated 23 September 2025

What this trial tests

NA trial testing VATs decortication in Parapneumonic Effussion in 95 participants. Not yet recruiting.

Timeline

25 October 2025

Primary endpoint
10 September 2027

10 February 2028

Quick facts

Lead sponsor	Assiut University
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	95
Start date	25 October 2025
Primary completion	10 September 2027
Estimated completion	10 February 2028
Sites	1 location across Egypt

Drugs / interventions tested

• VATs decortication
• VATs debridement

Conditions studied

• Parapneumonic Effussion — all drugs for Parapneumonic Effussion →

Sponsor

Assiut University

Who can join

18 and older, any sex, with Parapneumonic Effussion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Video-assisted thoracoscopic surgery (VATS) has revolutionised management of complicated parapneumonic effusion ( PPE). So our study is prospective cohort study will be conducted at Departments of Chest Diseases and Cardiothoracic Surgery, Assiut University Hospitals

* Aims: to determine the frequency of which VATS technique is needed (decortication versus debridement ) and to verify whether baseline RAPID score and pleural US parameters can predict which VATS procedure (decortication vs. debridement) in patients with complicated PPE will need, upon intra-operative exploration to compare the time to ICT removal after lung expansion and length of hospital stay in patients with PPE undergoing VATS via either debridement or decortication approach .
* Subjects: All patients with PPE presenting with suggestive symptoms,signs or radiological studies which display compatible patterns of PPE:

1. Inclusion criteria:

1. Age \> 18 years
2. Patients diagnosed with PPE who are confirmed by (aspiration of frank pus from pleural cavity, positive culture for bacterial infection, pleural fluid with a pH ⩽7.2 (measured by blood gas analyser), low glucose level (⩽3 mmol/L or ⩽55 mg•dL-1), lactate dehydrogenase (LDH) \>200 IU/L) in a patient with clinical evidence of infection .
3. Failed resolution of parapneumonic effusion.
2. Exclusion criteria:

1. Patients unfit for/ or declining surgical intervention.
2. Iatrogenic or traumatic pyothorax.
3. Haemothorax or chylothorax regardless the etiology.
4. Exudative pleural effusion due to medical conditions other than pneumonia .
* Sample size was calculated using Epi-info software version 7.2.5.0. The total sample size needed to detect such an estimate with 95% confidence level and 10% margin of error will be 95 patients
* Research outcome measures:

1. Primary (main):

* Number of the patients who will receive either VATS technique (and the respective percentage in relation to the total patients)
* Preoperative Adjusted RAPID score and US findings (fluid volume, echogenicity, pleural thickening, consolidation and other incidental findings).
* Assessment the radiological signs of lung expansion

CXR/US scores:

* Failure: Chest X-ray scoring 0 and chest US scoring 0.
* Partially successful: Chest X-ray scoring 1 or 2 and chest US scoring 1.
* Successful: Chest X-ray scoring 3 or 4, and chest US scoring 2 or 3.

B. Secondary (subsidiary):

* Time to ICT removal (days). ICT tube will be removed based on the MDT joint decision according to the patients' individual course. Tube removal is contemplated upon clinical resolution, complete fluid drainage, full lung expansion and absence of pleural air in CXR, in the absence of air leak, chest ultrasound to assess if there is residual pleural effusion.
* Length of Hospital Stay (days)
* Status at discharge (ICT removed or not)
* Patients reported outcomes:

* Postoperative pain (VAS) at discharge time
* Resumption of usual activities (self-care routine with assistance - unassisted self-care- other activities indoors- independent indoors and outdoors activities) by attending the patient to the hospital within 30 days post discharge.
* Mortality rate within 30 days postoperative.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.