Evaluating Different Modalities for Pleural Adhesiolysis at Assuit University Hospital

NCT ID: NCT03172052

Last Updated: 2017-06-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2020-06-30

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.

Conditions

Pleural Effusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

streptokinase

Intervention Type: DRUG

• 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)

Intervention Type: 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 thoracoscopy

Intervention Type: DEVICE

Medical thoracoscopy procedure will be carried at endoscopy unit at chest department via, semi rigid thoracoscope (LTF; Olympus; Tokyo, Japan).

Video assisted thoracoscopy (VATS)

Intervention Type: DEVICE

Video assisted thoracoscopy (VATS) at cardiothoracic surgery department.

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.

Group Type: EXPERIMENTAL

streptokinase

Intervention Type: DRUG

• 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)

Intervention Type: 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 thoracoscopy

Intervention Type: DEVICE

Medical thoracoscopy procedure will be carried at endoscopy unit at chest department via, semi rigid thoracoscope (LTF; Olympus; Tokyo, Japan).

Video assisted thoracoscopy (VATS)

Intervention Type: DEVICE

Video assisted thoracoscopy (VATS) at cardiothoracic surgery department.

Medical thoracoscopy procedure

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

Group Type: EXPERIMENTAL

streptokinase

Intervention Type: DRUG

• 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)

Intervention Type: 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 thoracoscopy

Intervention Type: DEVICE

Medical thoracoscopy procedure will be carried at endoscopy unit at chest department via, semi rigid thoracoscope (LTF; Olympus; Tokyo, Japan).

Video assisted thoracoscopy (VATS)

Intervention Type: DEVICE

Video assisted thoracoscopy (VATS) at cardiothoracic surgery department.

Video assisted thoracoscopy (VATS)

Video assisted thoracoscopy (VATS) at cardiothoracic surgery department.

Group Type: EXPERIMENTAL

streptokinase

Intervention Type: DRUG

• 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)

Intervention Type: 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 thoracoscopy

Intervention Type: DEVICE

Medical thoracoscopy procedure will be carried at endoscopy unit at chest department via, semi rigid thoracoscope (LTF; Olympus; Tokyo, Japan).

Video assisted thoracoscopy (VATS)

Intervention Type: DEVICE

Video assisted thoracoscopy (VATS) at cardiothoracic surgery department.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Medical thoracoscopy

Medical thoracoscopy procedure will be carried at endoscopy unit at chest department via, semi rigid thoracoscope (LTF; Olympus; Tokyo, Japan).

Intervention Type: DEVICE

Video assisted thoracoscopy (VATS)

Video assisted thoracoscopy (VATS) at cardiothoracic surgery department.

Intervention Type: DEVICE

Other Intervention Names

sedonase

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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Montaser Gamal Ahmed

assistent lecturer of Chest Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

17200064

Identifier Type: -

Identifier Source: org_study_id