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

July 6, 2016 updated by: Rambam Health Care Campus

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with recurrent symptomatic pleural effusion, the diagnosis was obtained by : - positive cytology for malignant cells in the fluid.

    • patients well known for malignancy, with exudative pleural effusion with no alternative diagnosis.
    • pleural biopsy - surgically obtained - with diagnosis of pleural malignancy
    • microscopic intraoperative findings suggestive of pleural malignancy.
  2. Patients who underwent prior to involvement in the study, draining of the pleural fluid with symptomatic improvement.
  3. Patients with rate of fluid accumulation less than 30 days.
  4. Patient who signed informed consent about being involved in the study.

Exclusion Criteria:

  1. Patients under the age of 18 years.
  2. Female patients who are Pregnant or nursing.
  3. Patients with rate of pleural effusion accumulation is more than 30 days.
  4. Patients who didn't show clinical improvement post proper draining of the fluid
  5. Patients who are hemodynamically or respiratory unstable.
  6. Patients with Empyema.
  7. Patients who are non functioning/ not active according to the Performance status.
  8. The type of malignancy which cause the malignant pleural effusion is Lymphoma.
  9. Patient who underwent pneumonectomy at the side of the fluid.
  10. previous pleurodesis at the side of pleural effusion.
  11. Chylothorax in the initial pleural tapping.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Talc Pleurodesis

For patients in this group, chest tube type PIGTAIL 10 - 14 Fr will be inserted by by chest ultrasound guided and under local anesthesia, allowing good draining of the hemithorax, in case of fluid discharges less than 250 cc/24, talc pleurodesis will be performed, chest tube will be removed 24 - 48 hours later on. the patient will be admitted in the hospital during the whole procedure course.

If the patient developed non expanded - trapped lung post chest tube insertion, or if he had persistence high chest tube output for more than 10 days, then the patient will remain with the PIGTAIL as an Indwelling Pleural Catheter.
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: 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%
Other Names:
  • Lidocaine hydrochloride
  • 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
Other Names:
  • PIGTAIL
Active Comparator: Indwelling Pleural Catheter

All patients from this group will have Indwelling Pleural Catheter insertion type PLEURAX inserted by ultrasound guided and under local anesthesia.

the patient and his/her family will be instructed and educated about the proper way of using the catheter, and how to perform pleural draining at home.

the duration of treatment with the Pleurax depends on the rate and amount of pleural effusion draining.
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%
Other Names:
  • Lidocaine hydrochloride
  • Esracain injection 2%
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one year of regular follow up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

April 4, 2016

First Submitted That Met QC Criteria

July 6, 2016

First Posted (Estimate)

July 7, 2016

Study Record Updates

Last Update Posted (Estimate)

July 7, 2016

Last Update Submitted That Met QC Criteria

July 6, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0371-15rmb

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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