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

Detection Rate by Blue Laser Imaging (BLI) of Secondary or Early Squamous Head and Neck Cancer in Patients Undergoing Elective Percutaneous Endoscopic Gastrostomy (PEG)

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04566367

Enrollment

140

Registered

2020-09-28

Start date

2020-09-22

Completion date

2024-08-31

Last updated

2023-07-13

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

Conditions

Head Neck Cancer, Esophageal Cancer, Gastrostomy

Keywords

esophageal cancer, Blue laser imaging, percutaneous endoscopic gastrostomy, head neck cancer

Brief summary

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.

Detailed 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.

Interventions

DIAGNOSTIC_TESTblue laser imaging

The intervention is the push on demand activation of blue laser imaging technique during gastroscopy.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Masking description

The participants don't know which arm they were allocated to.

Intervention model description

This study is a prospective randomised mono centric study with a one to one allocation in two different treatment arms.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Detection rate of a second cancer or precancerous lesions	The time frame is during the PEG insertion (approximately 15min)	The detection rates for malignant or premalignant lesions in participants with head neck tumors will be compared when using BLI and white light endoscopy

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026