Pleural EffusionPhase 4NCT03172052
Evaluating Different Modalities for Pleural Adhesiolysis at Assuit University Hospital
A Phase 4 study testing streptokinase, MESNA (2-mercaptoethane sulfonate Na) and Medical thoracoscopy in people with Pleural Effusion, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion
- What is being tested?
- streptokinase, MESNA (2-mercaptoethane sulfonate Na) and Medical thoracoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2017to 30 Jun 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
About this study
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.
Read the 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
- Being tested
- streptokinase, MESNA (2-mercaptoethane sulfonate Na), Medical thoracoscopy, Video assisted thoracoscopy (VATS)
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
streptokinaseDrug
Also called sedonase
- 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.
MESNA (2-mercaptoethane sulfonate Na)Drug
- 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 thoracoscopyDevice
Medical thoracoscopy procedure will be carried at endoscopy unit at chest department via, semi rigid thoracoscope (LTF; Olympus; Tokyo, Japan).
Video assisted thoracoscopy (VATS)Device
Video assisted thoracoscopy (VATS) at cardiothoracic surgery department.
| Study group | Role | What they receive |
|---|---|---|
| streptokinase instillation | Experimental | 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. Receives: Drug: streptokinase; Drug: MESNA (2-mercaptoethane sulfonate Na); Device: Medical thoracoscopy; Device: Video assisted thoracoscopy (VATS) |
| instillation of MESNA | Experimental | 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. Receives: Drug: streptokinase; Drug: MESNA (2-mercaptoethane sulfonate Na); Device: Medical thoracoscopy; Device: Video assisted thoracoscopy (VATS) |
| Medical thoracoscopy procedure | Experimental | Medical thoracoscopy procedure will be carried at endoscopy unit at chest department via, semi rigid thoracoscope Receives: Drug: streptokinase; Drug: MESNA (2-mercaptoethane sulfonate Na); Device: Medical thoracoscopy; Device: Video assisted thoracoscopy (VATS) |
| Video assisted thoracoscopy (VATS) | Experimental | Video assisted thoracoscopy (VATS) at cardiothoracic surgery department. Receives: Drug: streptokinase; Drug: MESNA (2-mercaptoethane sulfonate Na); Device: Medical thoracoscopy; Device: Video assisted thoracoscopy (VATS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start1 Aug 2017 (estimated)
- Primary completion1 Jun 2019 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Montaser Gamal Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172052
- Sponsor's protocol ID
- 17200064
- Status last verified
- Jun 2017
- First submitted
- 21 May 2017
- Last updated
- 6 Jun 2017
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Different Modalities for Pleural Adhesiolysis at Assuit University Hospital
- ClinicalTrials.gov ID
- NCT03172052
- Acronym / sponsor ID
- 17200064
- Conditions
- Pleural Effusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (estimated)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 1 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| streptokinase instillation | Experimental | Drug: streptokinase, Drug: MESNA (2-mercaptoethane sulfonate Na), Device: Medical thoracoscopy, Device: Video assisted thoracoscopy (VATS)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. |
| instillation of MESNA | Experimental | Drug: streptokinase, Drug: MESNA (2-mercaptoethane sulfonate Na), Device: Medical thoracoscopy, Device: Video assisted thoracoscopy (VATS)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 | Experimental | Drug: streptokinase, Drug: MESNA (2-mercaptoethane sulfonate Na), Device: Medical thoracoscopy, Device: Video assisted thoracoscopy (VATS)Medical thoracoscopy procedure will be carried at endoscopy unit at chest department via, semi rigid thoracoscope |
| Video assisted thoracoscopy (VATS) | Experimental | Drug: streptokinase, Drug: MESNA (2-mercaptoethane sulfonate Na), Device: Medical thoracoscopy, Device: Video assisted thoracoscopy (VATS)Video assisted thoracoscopy (VATS) at cardiothoracic surgery department. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| streptokinaseAlso: sedonase• 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 | Medical thoracoscopy procedure, Video assisted thoracoscopy (VATS), instillation of MESNA, streptokinase instillation |
| 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. | Drug | Medical thoracoscopy procedure, Video assisted thoracoscopy (VATS), instillation of MESNA, streptokinase instillation |
| Medical thoracoscopyMedical thoracoscopy procedure will be carried at endoscopy unit at chest department via, semi rigid thoracoscope (LTF; Olympus; Tokyo, Japan). | Device | Medical thoracoscopy procedure, Video assisted thoracoscopy (VATS), instillation of MESNA, streptokinase instillation |
| Video assisted thoracoscopy (VATS)Video assisted thoracoscopy (VATS) at cardiothoracic surgery department. | Device | Medical thoracoscopy procedure, Video assisted thoracoscopy (VATS), instillation of MESNA, streptokinase instillation |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing streptokinase, MESNA (2-mercaptoethane sulfonate Na) and Medical thoracoscopy in people with Pleural Effusion, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of adhesiolysis success (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2017.