Clinical trial NCT03172052: Evaluating Different Modalities for Pleural Adhesiolysis at Assuit University Hospital
Official title: Evaluating Different Modalities for Pleural Adhesiolysis at Assuit University Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pleural Effusion
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-06-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: interventional randomized clinical trial will be done at Assuit University Hospital ( Chest Department and Caridothoracic surgery department ),and all patients presented with complex septate pleural effusion in whom the symptoms excepted to be relieved by pleural fluid drainage will be included in our study within the two next years.

Detailed description: The goal in the management of pleural effusion is to provide symptomatic relief by removing fluid from the pleural space and to allow the treatment of the underlying disease. Despite the improvement in the management options of pleural effusion; intrapleural adhesions remain a significant problem in many patients with pleural disease. The presence of adhesions carry a poor prognostic factor in patients with exudative pleural effusions that it may render the drainage of pleural fluid difficulty inspite of tube being patent and correctly positioned.

Two options are currently available to deal with the problem of pleural adhesions, the first is chemical and the second is mechanical adhesiolysis . Chemical adhesiolysis means lysis of the adhesive bands medically by instillation intrapleural chemical agents e.g. streptokinase, urokinase, tissue plasminogen activator, streptodornase, deoxyribonuclease (human recombinant \[hr\]DNAase), single-chain urokinase plasminogen activator and the uncommonly used MESNA (2-mercaptoethane sulfonate Na) . Mechanical adhesiolysis means breaking up the adhesive bands and removing it by pulling and dissecting via medical thoracoscope, minimally invasive video assisted thoracoscopy (VATS) or more invasive thoracotomy.

Eligibility criteria: Inclusion Criteria:

* Patients with symptomatic pleural effusion in whom the symptoms excepted to be relieved by pleural fluid drainage.
* Presence of intrapleural adhesions as documented sonographically.
* Difficult thoracentesis.
* Failure of satisfactory pleural fluid drainage 24 hours following intercostal tube (ICT) placement provided that the tube was properly positioned and not obstructed.
* Written consent, free and informed.

Exclusion Criteria: patients have contraindications for any of our procedures will be excluded.

* Contraindications for streptokinase instillation i.e. (Previous allergic reaction, bronchopleural fistula, trauma or surgery within 48 hrs, history of hemorrhagic stroke, coagulation defects and previous streptokinase thrombolysis).
* Patients who are unfit for general anaesthesia.

Primary outcomes:
measure: measurement of adhesiolysis success
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: