NCT02674243

Brief Summary

This is prospective randomized control trial study. The aim of this study is to evaluate the efficacy of Iodopovidone solution for pleurodesis in palliative malignant pleural effusion (MPE) patients comparing to Talc. All adult patients who diagnosed MPE by cytology regardless primary tumor between December 1, 2015 and November 29, 2016 at Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University, Chiang Mai, Thailand will be enrolled in this study. The inform and consent will be applied in all patients before treatment. Patients will be randomized to two groups; Iodopovidone group (intervention group) and Talc group (control group)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2015

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

4.1 years

First QC Date

February 1, 2016

Last Update Submit

January 21, 2020

Conditions

Malignant Pleural Effusion

Keywords

Malignant pleural effusionPleurodesisTalcIodopovidone solutionPovidone-iodine

Outcome Measures

Primary Outcomes (1)

  • Success of treatment

    Success of treatment defined as chest drain can be removed within 1 week after intervention

    7 days

Secondary Outcomes (3)

  • Amount of pleural effusion after pleurodesis

    Until chest drain removal, an average of 7 days

  • Side effect

    with 24 hours after intervention

  • Length of hospital stay

    From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 30 days

Study Arms (2)

Iodopovidone group

EXPERIMENTAL

Patients who will be randomized for using iodopovidone solution for pleurodesis.

Drug: Iodopovidone solution

Talc group

ACTIVE COMPARATOR

Patients who will be randomized for using Talc for pleurodesis.

Drug: Talc

Interventions

Iodopovidone solutionDRUG

In this group, iodopovidone solution will be used as pleurodesis substance

Also known as: povidone-iodine solution
Iodopovidone group
TalcDRUG

In this group, Talc will be used as pleurodesis substance

Also known as: Talcum powder
Talc group

Eligibility Criteria

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

You may qualify if:

  • All MPE proved by cytology
  • After pleural effusion was released by chest tube drainage, lung was fully expanded

You may not qualify if:

  • Patients who have Karnofsky performance state ≤ 40
  • History of iodine allergy
  • History of morphine allergy
  • Abnormal thyroid hormones.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of surgery, Faculty of medicine, Chiang Mai University Hospital

Chiang Mai, Chaing Mai, 50200, Thailand

Location

MeSH Terms

Conditions

Pleural Effusion, Malignant

Interventions

Povidone-IodineTalc

Condition Hierarchy (Ancestors)

Pleural NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsPleural EffusionPleural DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

IodophorsIodine CompoundsInorganic ChemicalsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureMagnesium SilicatesMagnesium CompoundsSilicatesMineralsSilicic AcidSilicon DioxideSilicon Compounds

Study Officials

  • Apichat Tantraworasin

    Chiang Mai University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 1, 2016

First Posted

February 4, 2016

Study Start

November 1, 2015

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

January 23, 2020

Record last verified: 2020-01

Locations

TH(1)