Clinical trial: Standard Chest Tube Compared With a Small Catheter in Treating Malignant Pleural Effusion in Patients With Cancer (NCT00042770)

Eligibility criteria:
DISEASE CHARACTERISTICS:

          -  Radiologic evidence of a unilateral malignant pleural effusion requiring sclerosis or
             ongoing drainage because it is symptomatic (dyspnea and/or progressive fatigue)

               -  An asymptomatic patient is eligible if the patient underwent a prior
                  thoracentesis within the past 2 weeks and was symptomatic before the procedure

               -  No bilateral effusions by plain chest x-ray

          -  Histologically or cytologically confirmed solid tumor or hematologic malignancy

               -  Histologic confirmation of malignant cells in pleural fluid is not required

          -  Pleural spaces must be naive to pleurodesis attempts

               -  No prior intrapleural therapy (defined as a chest tube in place or placed to
                  drain an effusion, prior surgical pleurectomy, or any prior chemical or
                  mechanical pleurodesis on the ipsilateral side)

                    -  Placement of a small interventional radiology catheter for temporary
                       drainage is not considered intrapleural therapy as long as no sclerosant
                       medication was given and it has not been in place longer than 10 days

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  CTC 0-2

        Hematopoietic

          -  Granulocyte count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

        Pulmonary

          -  No active pleural infection

        Other

          -  No allergy to talc

          -  No surgical contraindication to talc usage

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

        Chemotherapy

          -  Concurrent systemic chemotherapy allowed

        Radiotherapy

          -  Concurrent palliative radiotherapy to a symptomatic lesion allowed except to the
             treated hemithorax within 30 days of the drainage procedure

        Surgery

          -  See Disease Characteristics

          -  Prior thoracotomies without specific pleural ablation (including lobectomy but not
             pneumonectomy) allowed

          -  Prior needle-based diagnostic interventions (fine-needle aspiration, small bore
             catheter drainage of less than 10 days, or thoracentesis) allowed
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea.  The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease.  He smokes 2 packs of cigarettes daily for the past 30 years.  On examination, there are decreased breath sounds and percussive dullness at the base of the left lung.  Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli.

Patient description (patient's own words): I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli.

Does the patient match the trial criteria? Entailment