NCT03172052

Evaluating Different Modalities for Pleural Adhesiolysis at Assuit University Hospital

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pleural Effusion

Interventions

Type	Name	Description
DRUG	streptokinase	• 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.
DRUG	MESNA (2-mercaptoethane sulfonate Na)	• 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.
DEVICE	Medical thoracoscopy	Medical thoracoscopy procedure will be carried at endoscopy unit at chest department via, semi rigid thoracoscope (LTF; Olympus; Tokyo, Japan).
DEVICE	Video assisted thoracoscopy (VATS)	Video assisted thoracoscopy (VATS) at cardiothoracic surgery department.

Timeline

• Start date: 2017-08-01
• Primary completion: 2019-06-01
• Completion: 2020-06-30
• First posted: 2017-06-01
• Last updated: 2017-06-06

Regulatory

• FDA-regulated drug study
• FDA-regulated device study