Clinical trial · Observational
Endoscopic Tri-Modal Imaging in Patients With Barrett's Esophagus
Endoscopic Tri-Modal Imaging for the Detection of High-Grade Dysplasia and Early Adenocarcinoma in Patients With Barrett's Esophagus: A Randomized Crossover Multi-center Study
NCT00586989CI-TRIAL-00020452ETMIcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is being done to determine if a new endoscope will help doctors identify pre-cancer or early cancer lesions in patients who have Barrett's esophagus. This new endoscope allows the doctor to look at the lining of the esophagus in 3 different ways by modifying light.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barretts Esophagus | — | UNRESOLVED | — |
| Early Esophageal Adenocarcinoma | Early Esophageal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| High Grade Dysplasia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Upper endoscopy with biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 1
- description
- Patient with Barrett's Esophagus with a history of High grade dysplasia or early esophageal adenocarcinoma
- interventionNames
- Procedure: Upper endoscopy with biopsy
Primary outcomes (1)
- measure
- 1. The number of patients and the number of lesions with HGD or early ACA detected with WLE and ETMI 2. The number of patients with HGD and early ACA detected with targeted biopsies only with ETMI and WLE
- timeFrame
- 2 years
Secondary outcomes (1)
- measure
- 1. The positive predictive value (PPV) of HRE and AFI 2. The reduction of false-positive findings after NBI (both the initial in vivo NBI assessment as well as later assessment based on still images)
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \> 18 years 2. Prior diagnosis of BE, defined as the presence of columnar-lined epithelium in the distal tubular esophagus with specialised intestinal metaplasia on histological investigation 3. Prior diagnosis of HGD or early ACA that was endoscopically inconspicuous according to the referring source 4. A minimum Barrett's length of C\>2M\>2 or C\<2M\>4 according to the Prague C\&M classification for the endoscopic appearance of BE 5. Ability to provide written informed consent Exclusion Criteria: 1. Description of a visibly suspicious lesion within the Barrett's segment according to the referring source 2. 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 delay in intervention for a period of 6 weeks (minimum interval between the two crossover endoscopies) 3. Prior endoscopic therapy for Barrett's lesions, such as photodynamic therapy or endoscopic mucosal resection (EMR) 4. Presence of esophagitis \> Los Angeles grade A classification 5. Presence of conditions precluding histological sampling of the esophagus (e.g., esophageal varices, coagulation disorders, anticoagulant therapy) 6. Pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.