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Clinical Trials/NL-OMON24455
NL-OMON24455
Recruiting
Not Applicable

Endoscopic Tri-Modal Imaging (ETMI) for the detection of early neoplasia in patients with Barrett’s esophagus (BE) in tertiary referral centers; a randomized cross-over multi-center study.

Academic Medical Center, Amsterdam0 sites84 target enrollmentTBD
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ConditionsBarrett's esophagusAutofuorescence imagingNarrow band imaging

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Barrett's esophagusAutofuorescence imagingNarrow band imaging
Sponsor
Academic Medical Center, Amsterdam
Enrollment
84
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

Curvers WL, Wong Kee Song LM, Wang K, Gostout CJ, Wallace MB, Wolfsen 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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Academic Medical Center, Amsterdam

Eligibility Criteria

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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).

Outcomes

Primary Outcomes

Not specified

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