NCT04743596

Brief Summary

In the last few years, high-definition (HD) videobronchoscopy has become widely available in the market and will progressively become the standard of care for airway inspection and sampling, as it provides substantially higher resolution images as compared to conventional white light bronchoscopy. Furthermore, in combination with improved video processor units, some HD videobronchoscopes offer post-processing real-time image enhancement (i-scan technology). Preliminary studies, performed in the setting of lung cancer, suggest that HD bronchoscopy with optical image enhancement (OE) may result in better detection of subtle vascular abnormalities in the airways, which are often associated with preneoplastic lesions. We hypothesize that HD videobronchoscopy could help identify bronchial involvement from sarcoidosis before it is (plainly) visible by conventional bronchoscopy.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
3 countries

5 active sites

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

First Submitted

Initial submission to the registry

February 3, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 8, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

March 17, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

January 10, 2023

Status Verified

February 1, 2022

Enrollment Period

1 year

First QC Date

February 3, 2021

Last Update Submit

January 9, 2023

Conditions

Sarcoidosis

Outcome Measures

Primary Outcomes (1)

  • Diagnostic yield of endobronchial biopsy guided by HD videobronchoscopy for the detection of granulomas

    The diagnostic yield will be calculated on a per patient basis (number of patients in whom the pathological examination of endobronchial biopsies shows non necrotizing granulomas/all the patients submitted to endobronchial biopsies)

    1 month

Secondary Outcomes (5)

  • Prevalence of airway abnormalities in patients with suspected sarcoidosis at HD bronchoscopy

    1 day

  • Prevalence of different patterns of airway abnormalities in patients with suspected sarcoidosis at HD videobronchoscopy

    1 day

  • Specificity for the detection of granulomas of the above 6 different patterns of airway abnormalities identified during HD bronchoscopy

    1 month

  • The interobserver agreement for the identification of the above 6 predefined patterns of airway abnormalities.

    1 month

  • Diagnostic yield for the detection of endobronchial granulomas according to clinical, radiological and endoscopic findings.

    6 months

Study Arms (1)

Sarcoidosis group

Consecutive patients with clinical and radiological (CT scan) suspect of sarcoidosis as assessed by a respiratory physician.

Device: High-Definition Videobronchoscopy

Interventions

High-Definition VideobronchoscopyDEVICE

Endoscopic inspection and endobronchial biopsy with standard forceps during high-definition videobronchoscopy.

Sarcoidosis group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive patients with clinical and radiological (CT scan) suspect of sarcoidosis as assessed by a respiratory physician

You may qualify if:

  • indication to a pathological confirmation of the clinical and radiological (CT) suspect of sarcoidosis;
  • age \> 18 years;
  • ASA score 1-3.

You may not qualify if:

  • inability to consent;
  • steroid therapy (at least 1 week) in the 2 months preceding bronchoscopy;
  • pregnancy;
  • uncontrolled coagulopathy;
  • contraindication to temporary interruption of anticoagulants or antiplatelet drugs, except aspirin;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Azienda Ospedaliero Universitaria di Bologna

Bologna, Italy

Location

Fondazione Policlinico Univeristario A. Gemelli IRCCS

Roma, 00168, Italy

Location

Academic Medical Centre

Amsterdam, Netherlands

Location

Central TB Research Institute

Moscow, Russia

Location

Research Institute of TB and Thoracic Surgery

Saint Petersburg, Russia

Location

Related Publications (1)

  • Livi V, Sivokozov I, Annema JT, Candoli P, Vasilev I, Kramer T, Ferrari M, Madan K, Fielding D, Murgu S, Cancellieri A, Semyonova LA, Puci M, Sotgiu G, Trisolini R. High-Definition Videobronchoscopy for the Diagnosis of Airway Involvement in Sarcoidosis: The Enhance Sarcoidosis Multicenter Study. Chest. 2023 Nov;164(5):1243-1252. doi: 10.1016/j.chest.2023.04.034. Epub 2023 Apr 28.

    PMID: 37121391DERIVED

MeSH Terms

Conditions

Sarcoidosis

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Study Officials

  • Rocco Trisolini, MD

    Catholic University of the Sacred Hearth

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2021

First Posted

February 8, 2021

Study Start

March 17, 2021

Primary Completion

March 31, 2022

Study Completion

September 30, 2022

Last Updated

January 10, 2023

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)NL(1)RU(2)