Clinical trial NCT04329000: On-demand PPI Therapy is Effective on Controlling Symptoms in Patients With Barrett's Esophagus.
Official title: The Impacts of On-demand Versus Continuous Esomeprazole Therapy on the Symptom Control and Histological Changes of Metaplastic Esophageal Epithelium in Patients With Barrett's Esophagus (EsoBE) - a Multicentre Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Barrett Esophagus
Proton Pump Inhibitor
Symptom
Reflux
Keywords: Barrett's Esophagus
Erosive esophagitis
Proton pump inhibitor
On-demand therapy
Continuous therapy
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 218
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized-controlled trial
Primary purpose: TREATMENT

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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Rates of progression, remaining unchanged, or regression of the distal esophageal metaplastic mucosa in both groups after 48 weeks
timeFrame: 48 weeks.
measure: Total symptom day
timeFrame: 48 weeks
measure: Number of tablets consumed
timeFrame: 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kaohsiung Veterans General Hospital.
name: SUNG-SHUO KAO, Bachelor
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Sharma P, Dent J, Armstrong D, Bergman JJ, Gossner L, Hoshihara Y, Jankowski JA, Junghard O, Lundell L, Tytgat GN, Vieth M. The development and validation of an endoscopic grading system for Barrett's esophagus: the Prague C & M criteria. Gastroenterology. 2006 Nov;131(5):1392-9. doi: 10.1053/j.gastro.2006.08.032. Epub 2006 Aug 16.
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