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Evaluating Different Modalities for Pleural Adhesiolysis at Assuit University Hospital

Primary Purpose

Pleural Effusion

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
streptokinase
MESNA (2-mercaptoethane sulfonate Na)
Medical thoracoscopy
Video assisted thoracoscopy (VATS)
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pleural Effusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    streptokinase instillation

    instillation of MESNA

    Medical thoracoscopy procedure

    Video assisted thoracoscopy (VATS)

    Arm 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.

    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.

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

    Video assisted thoracoscopy (VATS) at cardiothoracic surgery department.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 21, 2017
    Last Updated
    June 3, 2017
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03172052
    Brief Title
    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

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 1, 2017 (Anticipated)
    Primary Completion Date
    June 1, 2019 (Anticipated)
    Study Completion Date
    June 30, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    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

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pleural Effusion

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    streptokinase instillation
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    instillation of MESNA
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Medical thoracoscopy procedure
    Arm Type
    Experimental
    Arm Description
    Medical thoracoscopy procedure will be carried at endoscopy unit at chest department via, semi rigid thoracoscope
    Arm Title
    Video assisted thoracoscopy (VATS)
    Arm Type
    Experimental
    Arm Description
    Video assisted thoracoscopy (VATS) at cardiothoracic surgery department.
    Intervention Type
    Drug
    Intervention Name(s)
    streptokinase
    Other Intervention Name(s)
    sedonase
    Intervention 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.
    Intervention Type
    Drug
    Intervention Name(s)
    MESNA (2-mercaptoethane sulfonate Na)
    Intervention 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.
    Intervention Type
    Device
    Intervention Name(s)
    Medical thoracoscopy
    Intervention Description
    Medical thoracoscopy procedure will be carried at endoscopy unit at chest department via, semi rigid thoracoscope (LTF; Olympus; Tokyo, Japan).
    Intervention Type
    Device
    Intervention Name(s)
    Video assisted thoracoscopy (VATS)
    Intervention Description
    Video assisted thoracoscopy (VATS) at cardiothoracic surgery department.
    Primary Outcome Measure Information:
    Title
    measurement of adhesiolysis success
    Description
    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.
    Time Frame
    28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

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    Evaluating Different Modalities for Pleural Adhesiolysis at Assuit University Hospital

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