NCT02825095

Management of Malignant Pleural Effusion - Indwelling Pleural Catheter or Talc Pleurodesis

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Pleural Effusion, Malignant
• Lung Neoplasms

Interventions

Type	Name	Description
PROCEDURE	Talc Pleurodesis	chest tube type PIGTAIL 10 - 14 Fr will be inserted to the pleural space. In case of fluid discharges less than 250 cc/24, talc pleurodesis will be performed
PROCEDURE	Indwelling Pleural Catheter	Indwelling Pleural Catheter type PLEURAX will be inserted to the pleural space. the patients will be discharged with the pleural catheter.
PROCEDURE	chest ultrasound	All insertion of a chest drain will be guided by ultrasound
DRUG	Local anesthesia	Inserting a chest drain will be after local anesthesia with 10-20 mL of Lidocaine hydrochloride 20MG/ML - Esracain injection 2%
PROCEDURE	Chest Tube	chest tube type PIGTAIL 10 - 14 Fr will be inserted to the pleural space. In case of fluid discharges less than 250 cc/24, talc pleurodesis will be performed

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-05-01
• Completion: 2017-08-01
• First posted: 2016-07-07
• Last updated: 2016-07-07