TREAT-BE Study (Treatment With Resection and Endoscopic Ablation Techniques for Barrett's Esophagus)

Официальное название

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

Обзор

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).

Подробное описание

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 .

Вмешательства

• Процедура Endoscopic 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.
• Процедура Esophagectomy
  The esophagus is surgically removed
• Препарат Chemotherapy
  Chemical substances are used to treat cancer
• Лучевая терапия Radiation
  Cancer cells are destroyed by radiation therapy.

Первичные конечные точки

• Overall improvement of patient outcomes in patients treated with endoscopic eradication therapy (EET). [Срок оценки: 5 years]

Вторичные конечные точки (12)

• Long-term effectiveness or durability of EET in BE related neoplasia. [Срок оценки: 5 years]
• Quality of life (QOL) in patients undergoing endoscopic eradication therapies for Barrett's associated neoplasia [Срок оценки: 5 years]
• Recurrence rate of neoplasia [Срок оценки: 5 years]
• Recurrence rate of intestinal metaplasia [Срок оценки: 5 years]
• Recurrence rate based on baseline dysplasia, Barrett's length, and treatment modality [Срок оценки: 5 years]
• Persistence rate based on baseline dysplasia, Barrett's length, and treatment modality [Срок оценки: 5 years]
• Adverse event rates associated with EET for BE associated neoplasia and EAC. [Срок оценки: 5 years]
• Determine health-care utilization including endoscopic surveillance practices and outcomes in BE patients with and without neoplasia [Срок оценки: 5 years]
• Magnitude of risk factors for BE. [Срок оценки: 5 years]
• Magnitude of risk factors for BE related neoplasia. [Срок оценки: 5 years]
• Magnitude of risk factors for EAC. [Срок оценки: 5 years]
• Impact of endoscopic and radiologic imaging modalities. [Срок оценки: 5 years]

Критерии участия

Критерии включения

• Patients with Barrett's related neoplasia and dysplasia. Patients with esophageal cancer

Критерии исключения

• Patients with squamous cell carcinoma

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 4 центра

• UCLA Medical Center — Los Angeles
• Moffitt Cancer Center — Tampa
• Northwestern Memorial Hospital — Chicago
• Washington University — St Louis

Публикации

• 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. PMID 41758692
• 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 PMID 31982610
• 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. PMID 31004598

Идентификаторы

NCT: NCT02634645 · 14-2371

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗