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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04566367
Other study ID # JWGUHMED1-011
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 22, 2020
Est. completion date August 31, 2024

Study information

Verified date June 2023
Source Johann Wolfgang Goethe University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 140
Est. completion date August 31, 2024
Est. primary completion date February 2, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

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

Locations

Country Name City State
Germany Klinikum der J. W. Goethe-Universität Frankfurt am Main Hessen

Sponsors (1)

Lead Sponsor Collaborator
Georg Dultz

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
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