Evaluating Different Modalities for Pleural Adhesiolysis at Assuit University Hospital

Assiut University

Status and phase: Unknown; Phase 4

Conditions: Pleural Effusion

Treatments: Device: Medical thoracoscopy; Drug: streptokinase; Drug: MESNA (2-mercaptoethane sulfonate Na); Device: Video assisted thoracoscopy (VATS)

Study type: Interventional

Funder types: Other

Identifiers

NCT03172052

17200064

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 4 patient groups

streptokinase instillation

Experimental group

Description:

Chemical adhesiolysis by instillation of streptokinase at a dose of 250,000 I.U dissolved in 40 ml of normal saline will be instil in the pleural cavity through the chest tube. we planning to continue the daily instillation as long as the drained fluid volume is \>100 cc with a maximum of 14 doses and to stop further instillation if severe complication occurred and if drained fluid through the tube was \<100 cc in 24 h provided that tube is patent and properly positioned.

Treatment:

Device: Video assisted thoracoscopy (VATS)

Drug: streptokinase

Device: Medical thoracoscopy

Drug: MESNA (2-mercaptoethane sulfonate Na)

instillation of MESNA

Experimental group

Description:

Chemical adhesiolysis by instillation of MESNA at a dose of 1800 mg of MESNA i.e. 3 ampoules ( each ampoule contains 3ml and each ml contains 200 mg of MESNA) will be diluted with 20ml of Normal Saline and will be injected into the pleural cavity through the chest tube for three consecutive days.

Treatment:

Device: Video assisted thoracoscopy (VATS)

Drug: streptokinase

Device: Medical thoracoscopy

Drug: MESNA (2-mercaptoethane sulfonate Na)

Medical thoracoscopy procedure

Experimental group

Description:

Medical thoracoscopy procedure will be carried at endoscopy unit at chest department via, semi rigid thoracoscope

Treatment:

Device: Video assisted thoracoscopy (VATS)

Drug: streptokinase

Device: Medical thoracoscopy

Drug: MESNA (2-mercaptoethane sulfonate Na)

Video assisted thoracoscopy (VATS)

Experimental group

Description:

Video assisted thoracoscopy (VATS) at cardiothoracic surgery department.

Treatment:

Device: Video assisted thoracoscopy (VATS)

Drug: streptokinase

Device: Medical thoracoscopy

Drug: MESNA (2-mercaptoethane sulfonate Na)