NCT02500277

Brief Summary

This is a prospective study to assess the yield of pleural biopsy obtained with the routine flexible thoracoscopic biopsy forceps versus that obtained with a flexible cryoprobe during semirigid thoracoscopy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

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

January 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 16, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

3.5 years

First QC Date

July 13, 2015

Last Update Submit

August 29, 2018

Conditions

Pleural EffusionPleurisyTuberculosisMetastatic Malignancy

Keywords

thoracoscopypleuroscopysemirigid thoracoscopyflexible cryoprobecryobiopsypleural biopsy

Outcome Measures

Primary Outcomes (1)

  • Yield of pleural biopsy obtained with the routine flexible thoracoscopic biopsy forceps versus that obtained with a flexible cryoprobe during semirigid thoracoscopy

    The proportion of patients where a definitive histopathological diagnosis was obtained will be compared between the cryoprobe and flexible forceps biopsy

    One week

Secondary Outcomes (6)

  • Biopsy size

    One day

  • Duration of procedure

    One day

  • Ease of biopsy VAS

    One day

  • Artifacts

    One day

  • Tissue depth

    One day

  • +1 more secondary outcomes

Study Arms (2)

Cryobiopsy

ACTIVE COMPARATOR

Pleural biopsy with a flexible cryoprobe

Device: Cryoprobe pleural biopsy first

Forceps biopsy

ACTIVE COMPARATOR

Pleural biopsy with a flexible forceps

Device: Flexible forceps biopsy first

Interventions

Cryoprobe pleural biopsy firstDEVICE

Four pleural biopsy specimens will be obtained using the flexible cryoprobe (ERBOCRYOCA, ERBE, Tubingen, Germany; outer diameter 1.9 mm, length 900 mm) followed by 6-10 pleural biopsy specimens obtained using the flexible thoracoscopic forceps (FB-55CR, Olympus Medical Systems, 2 mm diameter).

Cryobiopsy
Flexible forceps biopsy firstDEVICE

Six to ten pleural biopsy specimens will be obtained using the flexible thoracoscopic forceps (FB-55CR, Olympus Medical Systems, 2 mm diameter) followed by four pleural biopsy specimens obtained using the flexible cryoprobe (ERBOCRYOCA, ERBE, Tubingen, Germany; outer diameter 1.9 mm, length 900 mm)

Forceps biopsy

Eligibility Criteria

Age12 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥12 years
  • Semirigid thoracoscopy being performed for diagnosis of the pleural effusion

You may not qualify if:

  • Age ≥80 years
  • SpO2 \<88% on room air
  • 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)

PGIMER

Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Pleural EffusionPleurisyTuberculosisNeoplasms

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract DiseasesRespiratory Tract InfectionsInfectionsMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Study Design

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

Study Record Dates

First Submitted

July 13, 2015

First Posted

July 16, 2015

Study Start

January 1, 2015

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

August 31, 2018

Record last verified: 2018-08

Locations

IN(1)