Endoscopy Every 2 Years or Only as Needed in Monitoring Patients With Barrett Esophagus

Gloucestershire Hospitals NHS Foundation Trust

Status: Unknown

Conditions: Esophageal Cancer; Precancerous Condition

Treatments: Procedure: diagnostic endoscopic procedure; Procedure: quality-of-life assessment; Procedure: screening method; Procedure: 2 yearly endoscopy; Procedure: endoscopic procedure; Procedure: endoscopic biopsy; Procedure: comparison of screening methods

Study type: Interventional

Funder types: Other

Identifiers

NCT00987857

CDR0000649890 (Registry Identifier)

ISRCTN54190466

NHS-GRH-HTA-05/12/01

Details and patient eligibility

About

RATIONALE: Screening tests may help doctors find cancer cells early and plan better treatment. It is not yet known whether endoscopy every 2 years is more effective than endoscopy only as needed in finding esophageal cancer in patients with Barrett esophagus.

PURPOSE: This randomized phase III trial is studying endoscopy every 2 years to see how well it works compared with endoscopy only as needed in monitoring patients with Barrett esophagus.

Full description

OBJECTIVES:

Primary

• To establish whether endoscopic surveillance every 2 years or endoscopy at need only is superior in terms of overall survival and, if neither is superior, whether endoscopy at need only is non-inferior to surveillance every 2 years in patients with Barrett esophagus.

Secondary

• To estimate the cost-effectiveness of endoscopic surveillance every 2 years as compared to endoscopy at need only.
• To establish whether there is a significant difference between endoscopic surveillance every 2 years or endoscopy at need only in terms of the incidence of esophageal cancer, gastric or esophageal cancer, or all cancers.
• To establish whether there is a significant difference between endoscopic surveillance every 2 years or endoscopy at need only in terms of the time to diagnosis of esophageal adenocarcinoma.
• To establish whether there is a significant difference between endoscopic surveillance every 2 years or endoscopy at need only in terms of the stage of esophageal adenocarcinoma at diagnosis using TNM staging.
• To establish whether there is a significant difference between endoscopic surveillance every 2 years or endoscopy at need only in terms of morbidity and mortality related to endoscopy, esophageal surgery, and other endoscopy-related interventions (e.g., ablation).
• To establish whether there is a significant difference between endoscopic surveillance every 2 years or endoscopy at need only in terms of the frequency of endoscopy.

OUTLINE: This is a multicenter study. Patients are stratified according to age at diagnosis (< 65 years vs ≥ 65 years), length of Barrett metaplasia segment including tongues (< 2 cm vs ≥ 2 cm and ≤ 3 cm vs > 3 cm and ≤ 8 cm vs > 8 cm), and newly diagnosed disease (defined as the date of endoscopy confirming Barrett metaplasia was within the past 4 months) (yes vs no). Patients are randomized to 1 of 2 intervention arms.

• Arm I: Patients undergo surveillance endoscopy with quadrantic biopsies taken every 2 cm. Patients undergo endoscopy every 2 years for a total of 6 endoscopies over 10 years.
• Arm II: Patients undergo endoscopy as needed over 10 years. All patients may undergo urgent endoscopy if they develop dysphagia, unexplained weight loss of > 7 lb, iron-deficiency anemia, recurrent vomiting, or worsening upper gastrointestinal symptoms.

All patients complete a questionnaire that includes a quality-of-life measure and questions about medication at baseline, every 2 years, and following key events (e.g., diagnosis of any cancer or high-grade dysplasia).

Enrollment: 3,400 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed circumferential Barrett metaplasia meeting 1 of the following criteria:

  • At least 1 cm from the gastro-esophageal junction
  • At least a 2 cm non-circumferential tongue of Barrett metaplasia

• Undergone endoscopy within the last 2 years to confirm Barrett metaplasia and exclude high-grade dysplasia and carcinoma

• No known high-grade dysplasia or carcinoma

PATIENT CHARACTERISTICS:

• Resident of the United Kingdom
• Informed of the risk of Barrett esophagus developing into esophageal cancer, either at the visit when the invitation letter is issued or on a documented previous occasion
• Able to undergo endoscopy
• No medical conditions that would make endoscopy difficult or hazardous

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

3,400 participants in 2 patient groups

2 yearly endoscopies

Active Comparator group

Description:

Two years endoscopies

Treatment:

Procedure: endoscopic biopsy

Procedure: diagnostic endoscopic procedure

Procedure: screening method

Procedure: 2 yearly endoscopy

Procedure: quality-of-life assessment

Procedure: endoscopic procedure

Procedure: comparison of screening methods

endoscopy at need

Experimental group

Description:

Endoscopy only when patient reports symptoms

Treatment:

Procedure: endoscopic biopsy

Procedure: diagnostic endoscopic procedure

Procedure: screening method

Procedure: 2 yearly endoscopy

Procedure: quality-of-life assessment

Procedure: endoscopic procedure

Procedure: comparison of screening methods