Evaluating Different Modalities for Pleural Adhesiolysis at Assuit University Hospital
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 主要终点
- measurement of adhesiolysis success
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: streptokinase (Drug)
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.
干预措施: MESNA (2-mercaptoethane sulfonate Na) (Drug)
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.
干预措施: Medical thoracoscopy (Device)
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.
干预措施: Video assisted thoracoscopy (VATS) (Device)
Medical thoracoscopy procedure
Medical thoracoscopy procedure will be carried at endoscopy unit at chest department via, semi rigid thoracoscope
干预措施: MESNA (2-mercaptoethane sulfonate Na) (Drug)
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.
干预措施: streptokinase (Drug)
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.
干预措施: MESNA (2-mercaptoethane sulfonate Na) (Drug)
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.
干预措施: Medical thoracoscopy (Device)
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.
干预措施: Video assisted thoracoscopy (VATS) (Device)
Medical thoracoscopy procedure
Medical thoracoscopy procedure will be carried at endoscopy unit at chest department via, semi rigid thoracoscope
干预措施: streptokinase (Drug)
Medical thoracoscopy procedure
Medical thoracoscopy procedure will be carried at endoscopy unit at chest department via, semi rigid thoracoscope
干预措施: Medical thoracoscopy (Device)
Medical thoracoscopy procedure
Medical thoracoscopy procedure will be carried at endoscopy unit at chest department via, semi rigid thoracoscope
干预措施: Video assisted thoracoscopy (VATS) (Device)
Video assisted thoracoscopy (VATS)
Video assisted thoracoscopy (VATS) at cardiothoracic surgery department.
干预措施: streptokinase (Drug)
Video assisted thoracoscopy (VATS)
Video assisted thoracoscopy (VATS) at cardiothoracic surgery department.
干预措施: MESNA (2-mercaptoethane sulfonate Na) (Drug)
Video assisted thoracoscopy (VATS)
Video assisted thoracoscopy (VATS) at cardiothoracic surgery department.
干预措施: Medical thoracoscopy (Device)
Video assisted thoracoscopy (VATS)
Video assisted thoracoscopy (VATS) at cardiothoracic surgery department.
干预措施: Video assisted thoracoscopy (VATS) (Device)
结局指标
主要结局
measurement of adhesiolysis success
时间窗: 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.
次要结局
未报告次要终点
研究者
Montaser Gamal Ahmed
assistent lecturer of Chest Department
Assiut University