Complete Resection of Barrett's Esophagus Harboring Neoplasia With Endoscopic Submucosal Dissection.
Launched by FRANCISCO BALDAQUE-SILVA · Aug 1, 2023
Trial Information
Current as of July 09, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a procedure called endoscopic submucosal dissection (ESD) for treating Barrett's esophagus, a condition where the lining of the esophagus changes and may lead to cancer. The goal of the trial is to see if ESD can safely and effectively remove all the abnormal tissue in the esophagus, which could reduce the risk of cancer more than traditional methods that involve multiple treatments. Participants in this trial will be individuals aged 65 to 74 who have Barrett's esophagus with certain characteristics, such as a segment that is at least 3 centimeters long and has been confirmed to show precancerous changes.
Those who join the trial can expect to undergo this advanced endoscopic procedure, which allows doctors to remove affected tissue in one piece while minimizing risks like bleeding or narrowing of the esophagus. The study is currently recruiting participants and aims to provide detailed information about the safety and effectiveness of ESD compared to current treatment methods. It's important to note that participants will be carefully monitored throughout the process, and the study will help improve understanding of how to manage Barrett's esophagus effectively.
Gender
ALL
Eligibility criteria
- • Inclusion Criteria:- 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 Criteria: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
About Francisco Baldaque Silva
Francisco Baldaque-Silva is a distinguished clinical trial sponsor known for his commitment to advancing medical research and improving patient outcomes. With a strong background in clinical pharmacology and a focus on innovative therapeutic solutions, he leads initiatives that bridge the gap between scientific discovery and clinical application. His expertise in trial design and regulatory compliance ensures that studies are conducted with the highest ethical standards and scientific rigor. Through collaboration with leading research institutions and healthcare professionals, Baldaque-Silva aims to facilitate the development of cutting-edge therapies that address unmet medical needs.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Stockholm, , Sweden
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported