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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard White Light Imaging | Active Comparator | 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 | In this group the participants will be examined by blue laser imaging technique first and secondly with standard white light during the same gastroscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blue laser imaging | Diagnostic Test | The intervention is the push on demand activation of blue laser imaging technique during gastroscopy. |
|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mireen Friedrich-Rust, Professor | Goethe University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum der J. W. Goethe-Universität | Frankfurt am Main | Hesse | 60590 | Germany |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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This study is a prospective randomised mono centric study with a one to one allocation in two different treatment arms.
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The participants don't know which arm they were allocated to.
| D004066 |
| Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |