Evaluating Different Modalities for Pleural Adhesiolysis at Assuit University Hospital

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.

Study Overview

• Status: Unknown
• Conditions: Pleural Effusion
• Intervention / Treatment: Drug: streptokinase; Drug: MESNA (2-mercaptoethane sulfonate Na); Device: Medical thoracoscopy; Device: Video assisted thoracoscopy (VATS)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: streptokinase instillation; 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.	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.; Other Names: sedonase; 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.
Experimental: instillation of MESNA; 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.	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.; Other Names: sedonase; 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.
Experimental: Medical thoracoscopy procedure; Medical thoracoscopy procedure will be carried at endoscopy unit at chest department via, semi rigid thoracoscope	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.; Other Names: sedonase; 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.
Experimental: Video assisted thoracoscopy (VATS); Video assisted thoracoscopy (VATS) at cardiothoracic surgery department.	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.; Other Names: sedonase; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measurement of adhesiolysis success	Failure of the procedure: still presence of intra pleural adhesion by chest sonoar. Partially successful: incomplete removal of intra pleural adhesions. Successful: complete removal of intra pleural adhesions.	28 days

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2017
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: May 21, 2017
• First Submitted That Met QC Criteria: May 28, 2017
• First Posted (Actual): June 1, 2017

Study Record Updates

• Last Update Posted (Actual): June 6, 2017
• Last Update Submitted That Met QC Criteria: June 3, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Protective Agents; Mesna; Streptokinase
• Other Study ID Numbers: 17200064

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No