Not Yet RecruitingNot Applicable

Ultrasound-guided Pigtail Catheter Versus Intercostal Tube Drainage of Non-traumatic Exudative Pleural Effusion

80 participantsStarted 2023-12-01

Plain-language summary

Primary Aims: To compare the performance of pigtail catheter to that of ICT in drainage of pleural effusion of medical aetiology regarding: 1. Various complications(mainly wound pain) that result from either therapeutic approach. 2. Success of complete drainage. 3. Compare the duration needed for complete drainage. Secondary Aims: To evaluate both techniques in terms of: 1. Degree of patient's mobility that either technique permits. 2. Percentage of patients that can be managed on outpatient settings by either approach

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age \> 18 years.
✓. Non-traumatic non-iatrogenic exudative pleural effusion necessitating drainage.
✓. Loculated pleural effusion where positive colour doppler sign is preserved

Exclusion criteria

✕. Traumatic or iatrogenic pleural effusion.
✕. Transudative pleural effusion (subjected to treatment of the underlying cause and diuretic therapy).
✕. Exudative pleural effusion amenable for medical treatment
✕. Large-volume, easily accessible, free non-loculated empyema.
✕. Pleural infections with loculated pleural effusion but showing negative colour doppler sign.
✕. Malignant pleural effusion with potentially inexpnasible underlying lung (thick pleural peel, central airway obstruction), life expectancy \< 1 month or asymptomatic.
✕. Patients with uncorrected bleeding tendency (INR \> 1.5, Platelet count \< 50.000/mm3).
✕. Inability or refusal to sign written consent.

What they're measuring

1) Degree of Pain/discomfort elicited by the Intervention:

Timeframe: 10 day

2) Adverse outcomes complicating either line of intervention

Timeframe: through study completion, an average of 1 year

3) Success of Complete Drainage

Timeframe: through study completion, an average of 1 year

4) Duration needed for Complete Drainage:

Timeframe: 15 day

Trial details

NCT IDNCT06099054

SponsorAssiut University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-01

Contact for this trial

Hossam Hassan, master

01008933979 hh6173303@gmail.com

View on ClinicalTrials.gov More Pleural Effusion trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age \> 18 years.
✓. Non-traumatic non-iatrogenic exudative pleural effusion necessitating drainage.
✓. Loculated pleural effusion where positive colour doppler sign is preserved

Exclusion criteria

✕. Traumatic or iatrogenic pleural effusion.
✕. Transudative pleural effusion (subjected to treatment of the underlying cause and diuretic therapy).
✕. Exudative pleural effusion amenable for medical treatment
✕. Large-volume, easily accessible, free non-loculated empyema.
✕. Pleural infections with loculated pleural effusion but showing negative colour doppler sign.
✕. Malignant pleural effusion with potentially inexpnasible underlying lung (thick pleural peel, central airway obstruction), life expectancy \< 1 month or asymptomatic.
✕. Patients with uncorrected bleeding tendency (INR \> 1.5, Platelet count \< 50.000/mm3).
✕. Inability or refusal to sign written consent.

What they're measuring

1) Degree of Pain/discomfort elicited by the Intervention:

Timeframe: 10 day

2) Adverse outcomes complicating either line of intervention

Timeframe: through study completion, an average of 1 year

3) Success of Complete Drainage

Timeframe: through study completion, an average of 1 year

4) Duration needed for Complete Drainage:

Timeframe: 15 day