A Multicenter Prospective Study Evaluating Outcomes of Endoscopic Eradication Therapy in Patients With Barrett's Esophagus Associated Neoplasia: The TREAT-BE (Treatment With Resection and Endoscopic Ablation Techniques for Barrett's Esophagus) Consortium
Summary
A prospective outcomes study in patients with and esophageal cancer (EAC) and Barrett's esophagus (BE) associated neoplasia being evaluated for endoscopic eradication therapy (EET).
Detailed description
Patients will be enrolled in this study at the participating centers when evaluated in gastro-intestinal (GI) clinics and endoscopy suites. Initial evaluation of patients will include collection of data on demographics, assessment of risk factors such as smoking, metabolic syndrome, family history and detailed medication history, and past surgical history. All patients will be complete questionnaires regarding Gastroesophageal Reflux Disease (GERD) symptoms, GERD related quality of life (QOL) and overall health related QOL. Details of all previous endoscopic and surgical evaluation along with histopathology data will be documented. Patients undergoing endoscopic evaluation at the participating centers will have their endoscopic and histopathology results documented. This will include data collection regarding use of advanced imaging techniques, details regarding tissue acquisition, EET and adverse events. Patients undergoing esophagectomy will have surgical details documented along with complications related to surgery. Similarly, details regarding chemoradiation treatments will be documented .
Arms & interventions
- ProcedureEndoscopic eradication therapies (EET)
Endoscopic eradication therapies (EET) includes endoscopic mucosal resection (EMR), which describes the process by which the area most likely to harbor highest grade of dysplasia/neoplasia is removed; radiofrequency ablation (RFA), which describes the process by which Barrett's segments are removed via burning/ablation; and cryotherapy.
- ProcedureEsophagectomy
The esophagus is surgically removed
- DrugChemotherapy
Chemical substances are used to treat cancer
- RadiationRadiation
Cancer cells are destroyed by radiation therapy.
Outcome measures
Primary
Overall improvement of patient outcomes in patients treated with endoscopic eradication therapy (EET).
A systematic, prospective collection of data from a large cohort of patients with BE and EAC undergoing EET will provide useful data in effort to improve overall patient outcomes.
Time frame: 5 years
Secondary
Long-term effectiveness or durability of EET in BE related neoplasia.
Time frame: 5 years
Quality of life (QOL) in patients undergoing endoscopic eradication therapies for Barrett's associated neoplasia
Time frame: 5 years
Recurrence rate of neoplasia
Time frame: 5 years
Recurrence rate of intestinal metaplasia
Time frame: 5 years
Recurrence rate based on baseline dysplasia, Barrett's length, and treatment modality
Time frame: 5 years
Persistence rate based on baseline dysplasia, Barrett's length, and treatment modality
Time frame: 5 years
Adverse event rates associated with EET for BE associated neoplasia and EAC.
Time frame: 5 years
Determine health-care utilization including endoscopic surveillance practices and outcomes in BE patients with and without neoplasia
Time frame: 5 years
Magnitude of risk factors for BE.
Time frame: 5 years
Magnitude of risk factors for BE related neoplasia.
Time frame: 5 years
Magnitude of risk factors for EAC.
Time frame: 5 years
Impact of endoscopic and radiologic imaging modalities.
Time frame: 5 years
Median time to recurrence of intestinal metaplasia
Time frame: 5 years
Median time to recurrence of neoplasia
Time frame: 5 years
Eligibility criteria
Study locations (4)
UCLA Medical Center
Los Angeles, California, 90095
Moffitt Cancer Center
Tampa, Florida, 33612
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Washington University
St Louis, Missouri, 63130
References
- Enke T, Pokala SK, Hensen C, Brennan C, Gallegos J, Hochheimer CJ, Muthusamy VR, Thaker AM, Kushnir V, Early D, Rastogi A, Hammad H, Edmundowicz SA, Komanduri S, Wani S. Recurrent Barrett's esophagus-related neoplasia is uncommon after successful endoscopic eradication therapy over long-term follow-up. Dis Esophagus. 2026 Jan 9;39(1):doag018. doi: 10.1093/dote/doag018.(PubMed)
- Wani S, Han S, Kushnir V, Early D, Mullady D, Hammad H, Brauer B, Thaker A, Simon V, Ezekwe E, Hollander T, Wood M, Rastogi A, Edmundowicz S, Muthusamy VR, Komanduri S. Recurrence Is Rare Following Complete Eradication of Intestinal Metaplasia in Patients With Barrett's Esophagus and Peaks at 18 Months. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2609-2617.e2. doi: 10.1016/j.cgh.2020.01.019. Epub 2020 Jan 23.(PubMed)
- Omar M, Thaker AM, Wani S, Simon V, Ezekwe E, Boniface M, Edmundowicz S, Obuch J, Cinnor B, Brauer BC, Wood M, Early DS, Lang GD, Mullady D, Hollander T, Kushnir V, Komanduri S, Muthusamy VR. Anatomic location of Barrett's esophagus recurrence after endoscopic eradication therapy: development of a simplified surveillance biopsy strategy. Gastrointest Endosc. 2019 Sep;90(3):395-403. doi: 10.1016/j.gie.2019.04.216. Epub 2019 Apr 17.(PubMed)