Status:
RECRUITING
Complete Resection of Barrett's Esophagus Harboring Neoplasia With Endoscopic Submucosal Dissection.
Lead Sponsor:
Francisco Baldaque-Silva
Conditions:
Barretts Esophagus With Dysplasia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Patients with Barrett's esophagus (BE) have a change in the lining of the esophagus. The normal one the lining of the esophagus changes to a lining similar to that of the intestine. The new mucosa has...
Detailed Description
Research plan Title Complete resection of Barrett's esophagus harboring neoplasia with endoscopic submucosal dissection. Background Barrett esophagus (BE) is a stablished risk factor for the developme...
Eligibility Criteria
Inclusion
- Long segment Barrett's esophagus with circular component \>= 3cm and maximum extent of 9cm.
- Presence of neoplastic Barrett's esophagus on previous biopsies confirmed by expert pathologist.
Exclusion
- Refractory esophagitis
- Presence of signs of deep submucosal invasion (\>sm1)
- Anticoagulation therapy that cannot be discontinued (ASA allowed)
- Barrett's esophagus length \> 9 cm (C and/or M)
- Immunosuppression that would contraindicate use of steroids.
- Diabetes Mellitus
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05983419
Start Date
August 1 2023
End Date
February 1 2026
Last Update
August 9 2023
Active Locations (1)
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1
Karolinska University Hospital
Stockholm, Sweden