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Third generation autofluorescence endoscopy compared with conventional autofluorescence endoscopy for the detection of early neoplasia in Barrett’s oesophagus.


- candidate number10967
- NTR NumberNTR3248
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-jan-2012
- Secondary IDsNL32287.018.10 / 10/094; CCMO / METC AMC
- Public TitleThird generation autofluorescence endoscopy compared with conventional autofluorescence endoscopy for the detection of early neoplasia in Barrett’s oesophagus.
- Scientific TitleThird generation autofluorescence endoscopy compared with conventional autofluorescence endoscopy for the detection of early neoplasia in Barrett’s oesophagus.
- ACRONYMTRAFI study
- hypothesisWe 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.
- Healt Condition(s) or Problem(s) studiedBarrett's esophagus, Neoplasia
- Inclusion criteria1. 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.
- Exclusion criteria1. 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).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2010
- planned closingdate1-jan-2013
- Target number of participants84
- InterventionsPatients 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
- Primary outcome1. Overall histological yield of AFI II and AFI III;
2. Targeted histological yield of AFI II and AFI III;
3. Number of patients diagnosed with HGIN/EC by AFI II and AFI III.
- Secondary outcome1. Number of abnormalities detected by AFI II and AFI III;
2. The value of re-inspection of AFI-positive areas with WLE;
3. The value of re-inspection of AFI-positive areas with NBI.
- TimepointsN/A
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES David Boerwinkel
- CONTACT for SCIENTIFIC QUERIES David Boerwinkel
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsCurvers WL, Herrero LA, Wallace MB, e.a. Endoscopic tri-modal imaging is more effective than standard endoscopy in identifying early-stage neoplasia in Barrett’s esophagus. Gastroenterology. 2010;139(4):1106-1114.
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD18-jan-2012 - 6-feb-2012


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