Blue Laser Imaging (BLI) for Detection of Secondary Head and Neck Cancer

Georg Dultz

Status: Active, not recruiting

Conditions: Esophageal Cancer; Head Neck Cancer; Gastrostomy

Treatments: Diagnostic Test: blue laser imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT04566367

JWGUHMED1-011

Details and patient eligibility

About

This study wants to focus on Carcinoma detection rates with blue laser imaging (BLI) for participants with head-neck cancer who need a percutaneous endoscopic gastrostomy (PEG). BLI is a new imaging technique that can easily be used within a standard gastroscopy.

Full description

Head-Neck cancers are a significant burden all around the world. Patients suffering from one tumor are at high risk for a second cancer or another precancerous lesion. Before or during cancer treatment a PEG is needed to maintain a sufficient calories intake. PEG is established by performing a standard gastroscopy.

This randomised study wants to compare the detection rates of standard white light endoscopy compared to the additional use of blue laser imaging for second cancers or precancerous lesions in participants presenting for PEG establishment.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All participants with the need of PEG due to head neck cancers or esophageal carcinoma

Exclusion criteria

• Minors, pregnant women, contraindication for endoscopy, contraindications for establishment of a PEG

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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140 participants in 2 patient groups

Standard White Light Imaging

Active Comparator group

Description:

In this group the participants will be examined by white light endoscopy first and secondly with blue laser imaging technique during the same gastroscopy.

Treatment:

Diagnostic Test: blue laser imaging

Blue Light Imaging

Experimental group

Description:

In this group the participants will be examined by blue laser imaging technique first and secondly with standard white light during the same gastroscopy.

Treatment:

Diagnostic Test: blue laser imaging