We hypothesize that the new AFI-III system – compared to the conventional AFI-II – enhances the distinction between early neoplasia and inflammation in BO and thus reduces the amount of false positive lesions, allowing for targeted sampling and…
ID
Bron
Verkorte titel
Aandoening
Barrett's oesophagus
early neoplasia
Barrett slokdarm
vroege neoplasie
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Overall histological yield of AFI II and AFI III;<br>
2. Targeted histological yield of AFI II and AFI III;<br>
3. Number of patients diagnosed with HGIN/EC by AFI II and AFI III.
Achtergrond van het onderzoek
In Barrett’s oesophagus (BO), autofluorescence imaging (AFI) suffers from high false-positive (FP) rates and improved targeted detection of high-grade intraepithelial neoplasia (HGIN) and early cancer (EC) by AFI can be compensated by obtaining random biopsies. Third generation AFI may improve detection of early neoplasia and reduce FP-rate. We hypothesize that the new AFI-III system – compared to the conventional AFI-II – enhances the distinction between early neoplasia and inflammation in BO and thus reduces the amount of false positive lesions, allowing for targeted sampling and better detection of early neoplasia in BO.
This is the first randomized crossover study comparing the third generation AFI system with the conventional AFI in a selected group of patients with BE with and without dysplasia.
Patients with Barrett's oesophagus with and without early neoplasia will undergo regular diagnostic imaging endoscopy for the detection of early neoplastic lesions. Patients are subsequently randomized to undergo either first AFI II or AFI III endoscopy, followed by a second endoscopy with the other system, in the same session by a second endoscopist, blinded for the results of the first endoscopy.
Doel van het onderzoek
We hypothesize that the new AFI-III system – compared to the conventional AFI-II – enhances the distinction between early neoplasia and inflammation in BO and thus reduces the amount of false positive lesions, allowing for targeted sampling and better detection of early neoplasia in BO.
This is the first randomized crossover study comparing the third generation AFI system with the conventional AFI in a selected group of patients with BE with and without dysplasia.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Patients will undergo regular diagnostic imaging endoscopy for the detection of early neoplastic lesions. Patients are subsequently randomized to undergo either first AFI II or AFI III endoscopy, followed by a second endoscopy with the other system, in the same session by a blinded endoscopist for the results of the first endoscopy
Publiek
David Boerwinkel
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5664571
d.f.boerwinkel@amc.uva.nl
Wetenschappelijk
David Boerwinkel
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5664571
d.f.boerwinkel@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Age over 18 years;
2. Prior diagnosis of BO defined as columnar lined esophageal epithelium upon endoscopy and intestinal metaplasia upon histological assessment of esophageal biopsies;
3. Confirmed diagnosis of EC, HGIN, LGIN or non-dysplastic BO;
4. Written informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Active erosive esophagitis grade B or higher according to the Los Angeles classification of erosive oesophagitis [17]17;
2. Advanced neoplastic lesion (i.e. any lesion considered not amendable for endoscopic treatment based its endoscopic appearance);
3. Unable to undergo biopsy sampling (e.g. due to coagulation disorders, esophageal varices).
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3094 |
| NTR-old | NTR3248 |
| CCMO | NL32287.018.10 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON34541 |