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A Study to Compare the Efficacy and Safety of Intrapleural Doxycycline Versus Iodopovidone for Performing Pleurodesis in Malignant Pleural Effusion

NCT02583282 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-10-06

No results posted yet for this study

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.

Conditions

  • Malignant Pleural Effusion

Interventions

OTHER

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.

OTHER

Iodopovidine

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.

Sponsors & Collaborators

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-01
Primary Completion
2020-12-31
Completion
2021-03-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02583282 on ClinicalTrials.gov