Increasing the accuracy for endoscopic detection of early Barrett neoplasia, by adding probe-based confocal laser endomicroscopy to endoscopic tri-modal imaging: A feasibility study on Endoscopic Quad-Modal Imaging (EQMI)

Increasing the accuracy for endoscopic detection of early Barrett neoplasia, by adding probe-based confocal laser endomicroscopy to endoscopic tri-modal imaging: A feasibility study on Endoscopic Quad-Modal Imaging (EQMI) - EQMI-study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON33330

Enrollment

Registered

2009-05-19

Start date

2010-01-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

(1) Barrett esophagus

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age > 18 years; - BO with a minimal circumferential length of 2 cm; - BO without dysplasia or with LGIN (i.e. surveillance patients) or patients with BO referred for endoscopic work-up of HGIN/early cancer; - Signed informed consent.

Exclusion criteria

Exclusion criteria: - Prior history of surgical or endoscopic treatment of esophageal neoplasia; - Presence of erosive oesophagitis (Los Angeles classification *B); - Inability to obtain biopsies or to perform an endoscopic resection (e.g. due to anticoagulation, coagulation disorders, varices); - Contraindication for fluorescein administration (e.g. allergy, pregnancy, beta-blocker use); - Unable to provide signed informed consent.

Design outcomes

Primary

Measure	Time frame
Study Phase 1: (1) Correlation of the real-time NBI evaluation with histological outcome; (2) Correlation of the real-time pCLE evaluation with histological outcome; (3) Reduction of the false positive rate of WLE and AFI with NBI; (4) Reduction of the false positive rate of WLE and AFI with pCLE. Study Phase 2: (1) Number of endoscopic resection specimens containing early neoplasia (i.e. HGIN/EC) upon histological evaluation; (2) Number of endoscopic resection specimens without early neoplasia upon histological evaluation; (3) Number of biopsies from areas graded as negative or indefinite upon endoscopy, containing early neoplasia upon histological evaluation.	—

Measure

Time frame

Study Phase 1: (1) Correlation of the real-time NBI evaluation with histological outcome; (2) Correlation of the real-time pCLE evaluation with histological outcome; (3) Reduction of the false positive rate of WLE and AFI with NBI; (4) Reduction of the false positive rate of WLE and AFI with pCLE. Study Phase 2: (1) Number of endoscopic resection specimens containing early neoplasia (i.e. HGIN/EC) upon histological evaluation; (2) Number of endoscopic resection specimens without early neoplasia upon histological evaluation; (3) Number of biopsies from areas graded as negative or indefinite upon endoscopy, containing early neoplasia upon histological evaluation.

—

Countries

Netherlands

Outcome results