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Evaluating Different Modalities for Pleural Adhesiolysis at Assuit University Hospital

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ClinicalTrials.gov Identifier: NCT03172052
Recruitment Status : Not yet recruiting
First Posted : June 1, 2017
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):
Montaser Gamal Ahmed, Assiut University

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.

Condition or disease Intervention/treatment Phase
Pleural Effusion Drug: streptokinase Drug: MESNA (2-mercaptoethane sulfonate Na) Device: Medical thoracoscopy Device: Video assisted thoracoscopy (VATS) Phase 4

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Evaluating Different Modalities for Pleural Adhesiolysis at Assuit University Hospital
Estimated Study Start Date : August 1, 2017
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Mesna

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 Name: 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 Name: 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 Name: 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 Name: 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.




Primary Outcome Measures :
  1. measurement of adhesiolysis success [ Time Frame: 28 days ]

    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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Responsible Party: Montaser Gamal Ahmed, assistent lecturer of Chest Department, Assiut University
ClinicalTrials.gov Identifier: NCT03172052     History of Changes
Other Study ID Numbers: 17200064
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: June 6, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases
Mesna
Streptokinase
Protective Agents
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action