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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Head Neck Cancer, Esophageal Cancer, Gastrostomy

Intervention / Treatment
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* Diagnostic Test: blue laser imaging


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This study is a prospective randomised mono centric study with a one to one allocation in two different treatment arms.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard White Light Imaging<br>In this group the participants will be examined by white light endoscopy first and secondly with blue laser imaging technique during the same gastroscopy. | Diagnostic Test: blue laser imaging<br>* The intervention is the push on demand activation of blue laser imaging technique during gastroscopy.<br>|
| Experimental: Blue Light Imaging<br>In this group the participants will be examined by blue laser imaging technique first and secondly with standard white light during the same gastroscopy. | Diagnostic Test: blue laser imaging<br>* The intervention is the push on demand activation of blue laser imaging technique during gastroscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophageal cancer, Blue laser imaging, percutaneous endoscopic gastrostomy, head neck cancer