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

Barrett Esophagus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04329000
• Other study ID #: VGHKSBE01
• Status: Completed
• Phase: N/A
• Start date: February 2, 2010
• Est. completion date: December 8, 2019

Study information

• Verified date: March 2020
• Source: Kaohsiung Veterans General Hospital.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: December 8, 2019
• Est. primary completion date: February 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus
• Proton Pump Inhibitor
• Reflux
• Symptom

Intervention

Drug:
• Esomeprazole 40mg
On-demand Esomeprazole 40 mg QD
• Esomeprazole
Continuous Esomeprazole 40 mg QD

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.

References & Publications (7)

Attwood SE, Lundell L, Hatlebakk JG, Eklund S, Junghard O, Galmiche JP, Ell C, Fiocca R, Lind T. Medical or surgical management of GERD patients with Barrett's esophagus: the LOTUS trial 3-year experience. J Gastrointest Surg. 2008 Oct;12(10):1646-54; discussion 1654-5. doi: 10.1007/s11605-008-0645-1. Epub 2008 Aug 16. — View Citation

Gatenby PA, Ramus JR, Caygill CP, Shepherd NA, Watson A. Relevance of the detection of intestinal metaplasia in non-dysplastic columnar-lined oesophagus. Scand J Gastroenterol. 2008;43(5):524-30. doi: 10.1080/00365520701879831. — View Citation

Kahrilas PJ. Clinical practice. Gastroesophageal reflux disease. N Engl J Med. 2008 Oct 16;359(16):1700-7. doi: 10.1056/NEJMcp0804684. Review. — View Citation

Kastelein F, Spaander MC, Steyerberg EW, Biermann K, Valkhoff VE, Kuipers EJ, Bruno MJ; ProBar Study Group. Proton pump inhibitors reduce the risk of neoplastic progression in patients with Barrett's esophagus. Clin Gastroenterol Hepatol. 2013 Apr;11(4):382-8. doi: 10.1016/j.cgh.2012.11.014. Epub 2012 Nov 28. — View Citation

Laine L, Ahnen D, McClain C, Solcia E, Walsh JH. Review article: potential gastrointestinal effects of long-term acid suppression with proton pump inhibitors. Aliment Pharmacol Ther. 2000 Jun;14(6):651-68. Review. — View 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. Epub 2006 Aug 16. — View Citation

Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R; Global Consensus Group. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006 Aug;101(8):1900-20; quiz 1943. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of progression, remaining unchanged, or regression of the distal esophageal metaplastic mucosa in both groups after 48 weeks	Progression, stationary, regression	48 weeks.
Primary	Total symptom day	Days with reflux symptoms	48 weeks
Primary	Number of tablets consumed	PPI tablets consumed during follow-up	48 weeks