On-demand PPI Therapy is Effective on Controlling Symptoms in Patients With Barrett's Esophagus.

Kaohsiung Veterans General Hospital

Status: Completed

Conditions: Proton Pump Inhibitor; Barrett Esophagus; Symptom; Reflux

Treatments: Drug: Esomeprazole 40mg; Drug: Esomeprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT04329000

VGHKSBE01

Details and patient eligibility

About

On-demand PPI therapy is feasible for the long-term treatment of patients with Barrett's esophagus.

Full description

Consecutive patients with symptomatic Barrett's esophagus are recruited and receive biopsy for esophageal metaplastic mucosa and gastric mucosa over the antrum and body during endoscopy on enrollment. The biopsy protocol for esophageal metaplastic mucosa is following Seattle protocol. GERD Q score will be conducted on enrollment. Additionally, blood sampling for CYP2C19 genotyping is also conducted on enrollment. The eligible subjects will be treated by 8-week esomeprazole, and are then randomly assigned to receive either maintenance or on-demand esomeprazole therapy (40 mg q.d.) for 40 weeks. The patients were asked to come back every four weeks for the recording of symptom days and PPI tablet consumption numbers. Follow-up endoscopy with biopsy for esophageal and gastric mucosa is performed at the end of the 48th weeks. We will compare the effects of maintenance and on-demand PPI therapy on (1) histological changes of esophageal metaplastic mucosa (2) symptom control (3) tablet consumption number

Enrollment: 218 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients between the ages of 20 and 80 years
• having symptoms of acid regurgitation, heart burn, or feeling of acidity in the stomach
• having Barrett's Esophagus proven by histology confirmation
• length of esophageal metaplastic mucosa equal to or longer than 1 centimeter

Exclusion criteria

• pregnancy,
• coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia)
• previous gastric surgery,
• allergic to esomeprazole,
• presence of dysplastic esophageal mucosa
• equivocal endoscopic diagnosis of Barrett's esophagus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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218 participants in 2 patient groups

On-demand PPI therapy

Experimental group

Description:

The patients in this group were advised to take PPI for 8 weeks continuously, followed by on-demand PPI therapy for the following 40 weeks.

Treatment:

Drug: Esomeprazole 40mg

Continuous PPI therapy

Active Comparator group

Description:

The patients in this group were advised to take PPI QD continuously for 48 weeks.

Treatment:

Drug: Esomeprazole