Vast improvements in oesophageal imaging

Not Applicable

Suspended

• Conditions: Oesophageal cancer; Cancer

• Registration Number: ISRCTN11347879
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-20
• Last Update Posted: 4 May 2020
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 370

Inclusion Criteria

1. Males and females over the age of 18 years
2. Ability to provide written, informed consent
3. For stream 1 (biopsies): patients with either suspected Barrett's Oesophagus presenting for endoscopy or patients with documented Barrett's Oesophagus presenting for follow-up endoscopy likely to require a biopsy
4. For stream 2 (endoscopic mucosal resections): patients with early stage oesophageal cancer
5. For stream 3 (oesophagectomy): patients with locally advanced oesophageal cancer which has not metastasised

Exclusion Criteria

1. Patients on anticoagulation undergoing high-risk procedures
2. Patients with esophageal varices that preclude biopsies
3. Patients with known eosinophilic esophagitis
4. Patients that are pregnant
5. Patients with a history of hemostasis disorders (Hemostasis disorders will include, but will not be limited to: patients with hemophilia or other congenitally acquired clotting factor deficiencies, patients with cirrhosis with coagulopathy, patients known to have thrombocytopenia (<100,000 plt/ul) and individuals with von Willibrand’s disease or other known platelet malfunction disorders)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Stream 1 patients (biopsies): the number of samples accurately classified as healthy/pre-cancerous lesions, measured using X-Ray Phase Contrast Imaging (XPCI) at the baseline endoscopy<br> Stream 2 patients (endoscopic mucosal resection): the number of samples where the margins of the tumor are correctly identified (with tolerance of 2 mm), measured using X-Ray Phase Contrast Imaging (XPCI) at the baseline endoscopy<br> Stream 3 patients (oesophagectomy): the number of samples where the margins of the tumor are correctly identified (with tolerance of 2 mm), measured using X-Ray Phase Contrast Imaging (XPCI) at the baseline endoscopy<br>

Secondary Outcome Measures

Name	Time	Method
There are no secondary outcome measures