NCT04039126

Brief Summary

Title of study: Comparison of the Effectiveness of Povidone-Iodine alone to Povidone-Iodine--Tetracycline Combination for Chemical Pleurodesis in Malignant Pleural Effusion. Research design: Prospective Randomized Controlled Clinical Trial. Background: Malignant pleural effusion (MPE) is commonly encountered in clinical practice among patients with malignancy. In addition to its association with major morbidities, it also poses a high risk of recurrence following drainage. Chemical pleurodesis is often required to achieve pleural adhesion and obliteration of the pleural space to prevent such recurrence. Several agents are in common use for chemical pleurodesis with mixed effectiveness.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 27, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

1.5 years

First QC Date

July 27, 2019

Last Update Submit

November 3, 2020

Conditions

Malignant Pleural Effusion

Keywords

MALIGNANT PLEURAL EFFUSSION

Outcome Measures

Primary Outcomes (1)

  • Success of pleurodesis

    classified as either a Complete Pleurodesis or Failed Pleurodesis. Complete pleurodesis defined as absence of pleural fluid re-accumulation on a chest radiograph at 1 and 3 months post-chemical pleurodesis, while Failed pleurodesis defined as pleural fluid re-accumulation requiring additional tube thoracostomy drainage before or at 1- 3 month follow up.

    1 AND 3 MONTH AFTER PLEURODESIS

Secondary Outcomes (1)

  • Adverse Effects from the chemical pleurodesis agent used

    immediate post procedure( 30minutes and 1 hour)

Study Arms (2)

PATIENTS WITH MALIGNANT PLEURAL EFFUSION

EXPERIMENTAL

PARTICIPANTS WITH MALIGNANT PLEURAL EFFUSIONS REQUIRING PLEURODESIS, COMBINATION OD POVIDONE IODOONE-TETRCYCLINE TO BE USED.

Drug: CHEMICAL PLEURODESIS WITH POVIDONE-IODINE-TETRACYCLINE COMBINATIONDrug: CHEMICAL PLEURODESIS WITH POVIDONE-IODINE ALONE

PATEINT WITH MALIGANT PLEURAL EFFUSION REQUIRNG PLEURODESIS

ACTIVE COMPARATOR

TO USE POVIDONE IODINE ALONE IN THIS GROUP

Drug: CHEMICAL PLEURODESIS WITH POVIDONE-IODINE ALONE

Interventions

CHEMICAL PLEURODESIS WITH POVIDONE-IODINE-TETRACYCLINE COMBINATIONDRUG

Pleurodesis is the obliteration of the pleural cavity by inducing adhesions of the visceral and parietal pleural layers, mostly used in patients with pleural effusions, pneumothorax (18). The use of pleurodesis to induce pleural symphysis between the pleural layers dates backs to the beginning of the 20th century by Benthune(19) and has continued to evolve with different Thoracic surgeons and researchers still looking for the ideal pleurodesis agent.

Also known as: PLEURODESIS
PATIENTS WITH MALIGNANT PLEURAL EFFUSION
CHEMICAL PLEURODESIS WITH POVIDONE-IODINE ALONEDRUG

20mls of 10% povidone-iodine (Wosan Solution Povidone-Iodine Usp 10%, Jawa International Limited) is mixed with 10mls of 1% xylocaine and 30mls of water for injection added to the mixture, making also a total volume of 60mls of the the single pleurodesis agents alone, which will be instilled into the pleural space via the closed thoracotomy tube.

Also known as: PLEURODESE
PATEINT WITH MALIGANT PLEURAL EFFUSION REQUIRNG PLEURODESISPATIENTS WITH MALIGNANT PLEURAL EFFUSION

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adult patients aged between18- 70 years presenting with pleural effusion in association with a malignant disease.
  • Patients with documented malignant pleural effusion ( i.e positive pleural fluid for malignant cells on pleural fluid cytology and/or positive pleural biopsy for malignant tissue).
  • Reaccumulation of an effusion after drainage or patients presenting with symptoms related to pleural fluid re-accumulation such as dyspnea, cough and chest pain.
  • Patient with full lung re-expansion after thoracostomy tube insertion and drainage of effusion.

You may not qualify if:

  • Patients with known hypersensitivity either to Povidone-iodine and/or Tetracycline
  • Failure to achieve full lung re-expansion following drainage of the effusion within 48hrs
  • Locoregional radiotherapy to the effusion side.
  • Loculated pleural effusion
  • Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College Hospital,

Ibadan, Oyo State, 200212, Nigeria

RECRUITING

Related Publications (3)

  • Psallidas I, Kalomenidis I, Porcel JM, Robinson BW, Stathopoulos GT. Malignant pleural effusion: from bench to bedside. Eur Respir Rev. 2016 Jun;25(140):189-98. doi: 10.1183/16000617.0019-2016.

    PMID: 27246596BACKGROUND

  • Antony VB, Loddenkemper R, Astoul P, Boutin C, Goldstraw P, Hott J, Rodriguez Panadero F, Sahn SA. Management of malignant pleural effusions. Eur Respir J. 2001 Aug;18(2):402-19. doi: 10.1183/09031936.01.00225601. No abstract available.

    PMID: 11529302BACKGROUND

  • Chernow B, Sahn SA. Carcinomatous involvement of the pleura: an analysis of 96 patients. Am J Med. 1977 Nov;63(5):695-702. doi: 10.1016/0002-9343(77)90154-1. No abstract available.

    PMID: 930945BACKGROUND

MeSH Terms

Conditions

Pleural Effusion, Malignant

Interventions

PleurodesisPovidone-Iodine

Condition Hierarchy (Ancestors)

Pleural NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsPleural EffusionPleural DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeuticsIodophorsIodine CompoundsInorganic ChemicalsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • catherine Falade, Prof.

    institute for advanced medical research and training, UI, IBADAN

    STUDY CHAIR

Central Study Contacts

Jibril Khalil, MMBS

CONTACT

+2348036602929jibril.khalil@gmail.com

MUDASSIRU SALAMI, MRCS

CONTACT

+2348023904206drmudathirsalami@yahoo.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
DOUBLE BLINDED, PARTIPANT ASIIGNED USING WINPEPI
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 27, 2019

First Posted

July 31, 2019

Study Start

June 20, 2019

Primary Completion

December 1, 2020

Study Completion

March 31, 2021

Last Updated

November 5, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

proforma of the study, with theinformation gathered during the study.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
as the study is being conducted
Access Criteria
via email

Locations

NG(1)