Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02583282 |
| Other study ID # |
INT/IEC/2015/232 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2015 |
| Est. completion date |
March 31, 2021 |
Study information
| Verified date |
October 2022 |
| Source |
Postgraduate Institute of Medical Education and Research |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
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.
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.
