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

Not Applicable

Active, not recruiting

• Conditions: Gastrostomy; Head Neck Cancer; Esophageal Cancer
• Interventions: Diagnostic Test: blue laser imaging

• Registration Number: NCT04566367
• Lead Sponsor: Georg Dultz

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.

Study Timeline

• Study First Submitted: 2018-12-02
• Study Start: 2020-09-22
• Study First Submitted QC: 2020-09-22
• Study First Posted: 2020-09-28
• Primary Completion: 2023-02-02
• Status Verified: 2023-06
• Last Update Submitted: 2023-07-12
• Last Update Posted: 2023-07-13
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard White Light Imaging	blue laser imaging	In this group the participants will be examined by white light endoscopy first and secondly with blue laser imaging technique during the same gastroscopy.
Blue Light Imaging	blue laser imaging	In this group the participants will be examined by blue laser imaging technique first and secondly with standard white light during the same gastroscopy.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Klinikum der J. W. Goethe-Universität; 🇩🇪 Frankfurt am Main, Hessen, Germany