Clinical Trial: Management of Malignant Pleural Effusion - Indwelling Pleural Catheter or Talc Pleurodesis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Management of Malignant Pleural Effusion - Indwelling Pleural Catheter or Talc Pleurodesis ; a Prospective Randomized Controlled Study.

Brief Summary: Prospective study of the effect of Talc Pleurodesis vs. Indwelling Pleural catheter in treatment of patients with malignant pleural effusion

Detailed Summary:

Randomized prospective study that will include 120 patients with malignant pleural effusion with high rate of accumulation; less than one month, The patients will be divided randomly for two groups, each group 60 patients, the first group will undergoes talc pleurodesis, the second group will undergoes Indwelling Pleural catheter insertion.

The two groups will be followed up for one year, starting at the time of intervention, after 14 days of intervention, after 30 days of intervention, once monthly for one year.

The patients will be evaluated according to the rate of complication; need for further intervention in each group, improvement of the quality of life, respiratory improvement, radiological evaluation based on chest Xray findings, rate and duration of admissions that are related to pleural effusion during the year of study.


Sponsor: Rambam Health Care Campus

Current Primary Outcome: change in Quality of Life [ Time Frame: one year of regular follow up. ]

the patients will be followed up 14 days post intervention, 30 days, once monthly for 12 months, the patient will fill questioner every month evaluating the quality of life, the daily activities and the degree of shortness of breath.


Original Primary Outcome: Same as current

Current Secondary Outcome: procedure and admissions [ Time Frame: one year ]

The patients will be evaluated for the number of admissions: e.g: how many times he/she was admitted to the hospital, duration of admissions; how many days he was admitted in the hospital each time and procedure related to pleural effusion; types and number of procedures


Original Secondary Outcome: Same as current

Information By: Rambam Health Care Campus

Dates:
Date Received: April 4, 2016
Date Started: August 2016
Date Completion: August 2017
Last Updated: July 6, 2016
Last Verified: July 2016