Clinical Trials Logo

Clinical Trial Summary

Malignant pleural effusion (MPE) arises in advanced-stages of malignancies and frequently heralds a poor prognosis.If the underlying malignancy is chemo sensitive (e.g., small-cell carcinoma of lung & lymphoma), systemic chemotherapy may control the pleural effusion. Instilling of sclerosing agents into the pleural cavity (pleurodesis) is a common method for the management of MPE. According to a recent survey, tetracycline or its derivative (doxycycline) is the preferred agent for performing pleurodesis at many centers. In a previous study from the investigators' center, the investigators have demonstrated equal efficacy of iodopovidone in comparison to talc in inducing pleural symphysis. Also, iodopovidone has been postulated to have anti-neoplastic effects and hence may help in reducing the drain output. Apart from these benefits iodopovidone is easily available and is cost effective. The investigators believe that iodopovidone will have better efficacy than doxycycline in inducing pleurodesis in malignant pleural effusion.


Clinical Trial Description

Introduction & Review of literature Malignant pleural effusion (MPE) arises in advanced-stages of malignancies and frequently heralds a poor prognosis. Most patients with MPE are symptomatic. The most common symptom is exertional dyspnea. Most patients undergo chemotherapy or local treatments to palliate symptoms such as dyspnea, cough & chest pain, to improve quality of life. If the underlying malignancy is chemo sensitive (e.g., small-cell carcinoma of lung & lymphoma), systemic chemotherapy may control the pleural effusion.1 However, when pleural effusion persists or reaccumulates after chemotherapy, the management of refractory MPE includes local therapeutic methods such as thoracentesis, pleurodesis, pleurectomy, or pleuroperitoneal shunting. Instilling of sclerosing agents into the pleural cavity (pleurodesis) is a common method for the management of MPE. For several years, various agents such as anti-neoplastics (e.g., nitrogen mustard, bleomycin), tetracycline derivatives, talc, erythromycin, silver nitrate, and povidone-iodine have been injected into the pleural cavity to create pleurodesis. According to a recent survey, tetracycline or its derivative (doxycycline) is the preferred agent for performing pleurodesis at many centers.7 However, intravenous preparation of doxycycline is not freely available and also induces severe inflammation in the pleura that results in severe chest pain and discomfort to the patient. In a previous study from the investigators' center, the investigators have demonstrated equal efficacy of iodopovidine in comparison to talc in inducing pleural symphysis.8 Also, iodopovidine has been postulated to have anti-neoplastic effects and hence may help in reducing the drain output. Apart from these benefits iodopovidine is easily available and is cost effective. The investigators believe that iodopovidone will have better efficacy than doxycycline in inducing pleurodesis in malignant pleural effusion. Study hypothesis In patients with malignant pleural effusion, pleurodesis with intrapleural instillation of iodopovidone will have better efficacy in comparison with doxycycline. Methods Study design: This will be a randomized double blind study conducted in the Department of Pulmonary Medicine, PGIMER, Chandigarh. Selection of cases: A total of 100 consecutive patients of malignant pleural effusion will be enrolled in the study. Patients will be equally randomized to undergo pleurodesis, either with intrapleural iodopovidone or intrapleural doxycycline. A written informed consent will be taken from all the patients participating in the present study Randomization: Patient will be randomized 1:1 to undergo pleurodesis either by instillation of intrapleural iodopovidone or intrapleural doxycycline. The randomization sequence will be computer generated. The sequence generated will be kept in a sealed opaque envelope and will be opened at the time of procedure Procedure: A chest tube (24-28 F) will be inserted through the fifth intercostal space in the mid-axillary line, to achieve complete drainage of the effusion and/or complete lung expansion. In case of large effusions, drainage will be spread over 24-48 h to prevent re-expansion pulmonary oedema. Pleurodesis will be performed when the daily drainage output will decrease to <150 mL/day and chest radiograph demonstrates apposition of pleural surfaces. In cases of pneumothorax, complete lung expansion and absence of any air leaks will be confirmed before instillation of the chemical agent. A chest radiograph will be performed to confirm complete re-expansion. Normal saline solution (50 mL) containing lignocaine (2 mg/kg ideal body weight) will be infused through the chest tube. Simultaneously, tramadol (100 mg) will be administered intravenously for analgesia. After 15 minutes pleurodesis will be performed either by instillation of doxycycline or by iodopovidone. Doxycycline: 500 mg of doxycycline will be dissolved in 50 ml of normal saline. The combination will then be instilled through the chest tube in the pleural cavity and the chest tube drain will be clamped for 4 hours. Iodopovidone: 20 ml of 10% betadine (Microshield, Johnson and Johnson, Solan, India) will be dissolved in 80 mL of normal saline. The combination will then be instilled through the chest tube in the pleural cavity and the chest tube drain will be clamped for 4 hours. The chest tube will be flushed with 50 mL of normal saline after instillation of study drug (doxycycline or iodopovidone). Endpoint: The chest tube will be removed if the drainage output is less than 100mL of pleural fluid and there is complete lung re-expansion with no residual pneumothorax on chest radiograph. Pulse, blood pressure, respiratory rate and temperature will be measured before and every 30 minutes after the procedure for 6 hours. Chest pain after pleurodesis will be recorded on a visual analogue scale (VAS) of 0-100 mm. Patients will be given additional intravenous tramadol (50 mg) on an as-needed basis after the procedure. Any complications related to the procedure will be recorded. Complications such as hypotension, fever, acute respiratory failure and empyema will be noted. Patients will be followed up at 1 week, at 1, 3 and 6 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02583282
Study type Interventional
Source Postgraduate Institute of Medical Education and Research
Contact
Status Completed
Phase N/A
Start date August 1, 2015
Completion date March 31, 2021

See also
  Status Clinical Trial Phase
Completed NCT00052338 - Bortezomib Plus Gemcitabine and Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer Phase 1
Recruiting NCT06421610 - OPC5: Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) in Patients With Malignant Pleural Effusion. Phase 1
Recruiting NCT04793607 - Interventions for Malignant Pleural Effusions Impact on Fatigue
Recruiting NCT03987087 - A Randomized Study of Primary Tumor Radiotherapy for Patients With MPE Stage IV NSCLC Phase 2
Recruiting NCT02942043 - Bevacizumab in the Treatment of Malignant Pleural Effusions of Non-squamous Non-small Cell Lung Cancer Phase 2
Completed NCT01997190 - Intrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion Phase 1
Completed NCT00564733 - FDG-Labeled PET Scan in Planning Chemotherapy in Treating Patients With Stage IIIB or IV Non-Small Cell Lung Cancer Phase 2
Not yet recruiting NCT04131231 - Safety and Effectiveness of MPCD Therapy on the Treatment of Malignant Pleural Effusion N/A
Completed NCT02674243 - Efficacy of Iodopovidone Versus Talc in Palliative Malignant Pleural Effusion Phase 3
Terminated NCT01004510 - Zometa Adjuvant Treatment of Malignant Pleural Effusion Due To Non-Small Cell Lung Cancer Phase 2
Completed NCT00528645 - AZD0530 in Treating Patients With Extensive Stage Small Cell Lung Cancer Phase 2
Recruiting NCT00313066 - Comparison the Level of CTGF Protein and Related Cytokine in Pleural Effusion Phase 4
Terminated NCT04236037 - Ultrasound-guided Biopsy of the Pleura as a Supplement to Extraction of Fluid in Patients With One-sided Fluid in the Pleura N/A
Completed NCT05372055 - Malignant Pleural Effusions: Evaluating the psYchosocial Impact of Indwelling Pleural Catheters on Patients
Not yet recruiting NCT04914598 - A Phase Ⅲ Clinical Study of Combined Cisplatin Versus Placebo Combined With Intracavitary Cisplatin Injection in the Treatment of Malignant Pleural Effusions Phase 3
Recruiting NCT04322136 - AMPLE-3: IPC Plus Talc vs VATS in Management of Malignant Pleural Effusion N/A
Recruiting NCT03973957 - Talc Outpatient Pleurodesis With Indwelling Catheter N/A
Recruiting NCT05923515 - A Phase I Study of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion Phase 1
Completed NCT02649894 - Safety and Effectiveness of a New Pleural Catheter for Symptomatic, Recurrent, MPEs Versus Approved Pleural Catheter N/A
Recruiting NCT03403855 - Rocket® Pleural Catheters: QOL, Feasibility and Satisfaction in Recurrent MPE Patients N/A