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

NCT04566367 — Not applicable, Unknown, 140 participants, Georg Dultz

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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)

Registry	NCT04566367
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: single, diagnostic
Enrollment	140 (Estimated)
Sponsor	Georg Dultz (Other)
Conditions	Head Neck Cancer, Esophageal Cancer, Gastrostomy
Interventions	blue laser imaging (Diagnostic test)
Dates	start 2020-09-22, primary completion 2023-02-02, completion 2024-08-31 (estimated), first posted 2020-09-28, last updated 2023-07-13
Locations	1 site in Germany

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Standard White Light Imaging	Active comparator	Diagnostic Test: 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	Experimental	Diagnostic Test: 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.

blue laser imaging (Diagnostic test): The intervention is the push on demand activation of blue laser imaging technique during gastroscopy.

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Klinikum der J. W. Goethe-Universität	Frankfurt am Main, Hesse	Germany

+Investigators

Mireen Friedrich-Rust, Professor, Principal investigator, Goethe University

My Notes

Public

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