ETMI improves the detection of early neoplasia in Barrett's esophagus.
ID
Bron
Verkorte titel
Aandoening
Barrett's esophagus
Autofuorescence imaging
Narrow band imaging
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. The number of patients and the number of lesions with early neoplasia detected with SVE and ETMI;
2. The number of patients with early neoplasia detected with targeted biopsies only with ETMI and SVE.
Achtergrond van het onderzoek
Endoscopic Trimodal Imaging is a new imaging device that incorperates high-resolution white light endoscopy with autofluorescence imaging and narrow band imaging. Our aim of this study is to compare ETMI with standard video endoscopy for the detection of early neoplastic lesions in Barrett's esophagus. In this study high-risk patients reffered for the work-up of high-grade dysplasia or early cancer will included. All prodedures will performed by expert endoscopists in this field in 4 tertiary referal centres for the endoscopic treatment of early Barrett's neoplasia. All patients will undergo two endoscopies (ETMI and SVE) perfromed by two different endoscopists with an interval of 6-12 weeks.
Doel van het onderzoek
ETMI improves the detection of early neoplasia in Barrett's esophagus.
Onderzoeksproduct en/of interventie
In this study we will compare diagnostic endoscopy techniques for the detection of early enoplasia in Barrett's esophagus. These techniques are standard video endoscopy (the current standard) and
Endoscopic Tri-Modal Imaging (ETMI). Patients will undergo two consecutive endoscopies in an interval of 8-12 weeks. One of the two aformentioned techniques will be randomly assigned to the first procedure, the second procedure will subsequently be performed with the other technique by a second endoscopist.
The primary outcome will be the number of lesions and patients with early neoplasia detected with standard video endoscopy and ETMI.
Publiek
Bldg. C2-210, Meibergdreef
J.J.G.H.M. Bergman
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5669111
j.j.bergman@amc.uva.nl
Wetenschappelijk
Bldg. C2-210, Meibergdreef
J.J.G.H.M. Bergman
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5669111
j.j.bergman@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Age > 18 years;
2. Prior diagnosis of BE defined as the presence of columnar lined epithelium in the tubular esophagus with specialised intestinal metaplasia on histological investigation;
3. Prior diagnosis of high-grade dysplasia or early cancer that was endoscopically inconspicuous according to the referring physician. Review of the pathology slides is not required for inclusion;
4. A minimum Barrett’s length of C>2M>2 or C<2M>4 according to the Prague C&M classification of the endoscopic appearance of BE;
4. Written informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Presence of active erosive esophagitis > grade A according to the Los Angles classification of erosive esophagitis;
2. Description of an endoscopically visible suspicious lesion in the Barrett’s segment in the referring center;
3. Presence of conditions precluding histological sampling of the esophagus (e.g. esophageal varices, coagulation disorders, anticoagulant therapy);
4. At the first endoscopy: the presence of a type 0-I or type 0-III lesion or a lesion that, according to the discretion of the endoscopist, does not allow a delay in intervention for a period of 6 weeks (interval between the two cross-over endoscopies).
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL921 |
NTR-old | NTR945 |
Ander register | : |
ISRCTN | ISRCTN68328077 |
Samenvatting resultaten
HC, Ragunath R, Fockens P, Bergman JJ. Endoscopic Tri-Modal Imaging
(ETMI) for the Detection of Dysplastic Lesions in Barrett's Esophagus;
a multi-centre feasibility study. Endosc 2006; 38 (suppl II) A34.