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
Verified date | March 2020 |
Source | Kaohsiung Veterans General Hospital. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
On-demand PPI therapy is feasible for the long-term treatment of patients with Barrett's esophagus.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Kaohsiung Veterans General Hospital. |
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
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 |
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