NCT03449602

Brief Summary

Consecutive patients who are planned to undergo a medical thoracoscopy for obtaining pleural biopsies will be enrolled in the study. One hundred subjects will be randomized in 1:1 ratio to undergo thoracoscopy to the following groups: Group A (mini-thoracoscopy) Group B (Conventional rigid thoracoscopy) Primary outcome: (a) diagnostic sensitivity of mini-thoracoscopy and conventional rigid thoracoscopy in the diagnosis of exudative pleural effusions

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

February 17, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

5.6 years

First QC Date

February 17, 2018

Last Update Submit

March 28, 2023

Conditions

Pleural Effusion

Keywords

thoracoscopypleuroscopymetastatic cancerlung cancermalignant pleural effusiontuberculosis

Outcome Measures

Primary Outcomes (2)

  • Diagnostic sensitivity (intention-to-treat)

    Difference between the diagnostic sensitivity of mini-thoracoscopy and conventional rigid thoracoscopy in the diagnosis of exudative pleural effusions by calculating the number of true positives diagnosed by thoracoscopic biopsy in the two groups out of the total diseased

    6 months

  • Diagnostic sensitivity (per protocol)

    Diagnostic sensitivity of mini-thoracoscopy and conventional rigid thoracoscopy in the diagnosis of exudative pleural effusions by calculating the number of true positives diagnosed by thoracocopic biopsy. In this analysis, the subjects crossed over to the rigid group (due to failure of minirigid to yield biopsy tissue) will be considered in the rigid group

    6 months

Secondary Outcomes (9)

  • Sedative and analgesic dose

    1 day

  • Pain scores by visual analog scale

    1 day

  • Diagnostic specificity

    6 months

  • Adverse effects

    1 month

  • Scope maneuverability

    1 day

  • +4 more secondary outcomes

Study Arms (2)

Mini-thoraoscopy

EXPERIMENTAL

The mini-thoracoscope manufactured by Richard Wolf GmbH, Knettligen, Germany will be used for performing thoracoscopic pleural biopsies. It has an outer diameter of 5.5 mm and a working channel diameter of 3.5 mm.

Device: Mini-thoracoscopy

Conventional rigid thoracoscopy

ACTIVE COMPARATOR

The rigid thoracoscope manufactured by Richard Wolf GmbH, Knettligen, Germany will be used for performing thoracoscopic pleural biopsies. It has an outer diameter of 10 mm and channel internal diameter of 5 mm.

Device: Conventional rigid thoraoscopy

Interventions

Mini-thoracoscopyDEVICE

Thoracoscopic pleural biopsy with the mini-thoracoscope

Mini-thoraoscopy
Conventional rigid thoraoscopyDEVICE

Thoracoscopic pleural biopsy with the conventional rigid thoraoscope

Conventional rigid thoracoscopy

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Medical thoracoscopy being performed for obtaining a pleural biopsy

You may not qualify if:

  • PaO2/FIO2\< 300; Hemodynamic instability Myocardial infarction or unstable angina in the last 6 wk Lack of pleural space due to adhesions Uncorrected coagulopathy Failure to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, 160012, India

RECRUITING

MeSH Terms

Conditions

Pleural EffusionNeoplasm MetastasisLung NeoplasmsPleural Effusion, MalignantTuberculosis

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract DiseasesNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesPleural NeoplasmsMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Central Study Contacts

Sahajal Dhooria, MD, DM

CONTACT

+919530661388sahajal@gmail.com

Ritesh Agarwal, MD, DM

CONTACT

+919478402976agarwal.ritesh@outlook.in

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 17, 2018

First Posted

February 28, 2018

Study Start

March 1, 2018

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

March 29, 2023

Record last verified: 2023-03

Locations

IN(1)