Evaluating Different Modalities for Pleural Adhesiolysis at Assuit University Hospital

June 3, 2017 updated by: Montaser Gamal Ahmed, Assiut University
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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 6, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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