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Recruiting NCT02634645

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

— Observational Barrett's Esophagus Esophageal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endoscopic eradication therapies (EET), Esophagectomy, Chemotherapy, Radiation.
Who it may be relevant to
Registry conditions: Barrett's Esophagus, Esophageal Cancer. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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 .

Interventions

  • Procedure 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.
  • Procedure Esophagectomy
    The esophagus is surgically removed
  • Drug Chemotherapy
    Chemical substances are used to treat cancer
  • Radiation Radiation
    Cancer cells are destroyed by radiation therapy.

Primary outcome measures

  • Overall improvement of patient outcomes in patients treated with endoscopic eradication therapy (EET). [Time frame: 5 years]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Patients with squamous cell carcinoma

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 4 centers
  • UCLA Medical Center — Los Angeles
  • Moffitt Cancer Center — Tampa
  • Northwestern Memorial Hospital — Chicago
  • Washington University — St Louis

Publications

  • 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

Identifiers

NCT: NCT02634645 · 14-2371

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗