Evaluating Different Modalities for Pleural Adhesiolysis at Assuit University Hospital
1 other identifier
interventional
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2017
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2017
CompletedFirst Posted
Study publicly available on registry
June 1, 2017
CompletedStudy Start
First participant enrolled
August 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedJune 6, 2017
June 1, 2017
1.8 years
May 21, 2017
June 3, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
streptokinase instillation
EXPERIMENTALChemical 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.
instillation of MESNA
EXPERIMENTALChemical 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
EXPERIMENTALMedical thoracoscopy procedure will be carried at endoscopy unit at chest department via, semi rigid thoracoscope
Video assisted thoracoscopy (VATS)
EXPERIMENTALVideo assisted thoracoscopy (VATS) at cardiothoracic surgery department.
Interventions
• 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.
• 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 (LTF; Olympus; Tokyo, Japan).
Video assisted thoracoscopy (VATS) at cardiothoracic surgery department.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistent lecturer of Chest Department
Study Record Dates
First Submitted
May 21, 2017
First Posted
June 1, 2017
Study Start
August 1, 2017
Primary Completion
June 1, 2019
Study Completion
June 30, 2020
Last Updated
June 6, 2017
Record last verified: 2017-06