Endoscopic therapy for gastroesophageal reflux disease: what have we learned and what needs to be done?
GERD is a common, morbid, and expensive-to-treat disease. Clinicians have a clearly defined "therapeutic bar" for the efficacy of GERD therapy established from extensive study of current pharmacologic and surgical therapies. Endoscopic therapies for GERD are promising technologies that probably will find clinical application in subsets of patients with GERD. Integration of these new endoscopic GERD therapies into routine clinical practice requires more information from carefully performed and analyzed trials. Issues that still need to be addressed include the efficacy of these devices compared with placebo, efficacy compared with other endoscopic techniques, and efficacy versus current therapies. Addressing these issues requires the performance of well-designed, blinded studies using sham techniques and measuring clinically relevant outcomes using validated instruments. Once efficacy has been established, durability of response needs to be clearly determined. Intensive postmarketing surveillance, device registries, and long-term clinical follow-up studies will be able to document durability. The effect of retreatment for relapses or suboptimal initial treatment response should also be determined. Safety can best be established with extensive postmarketing surveillance and device registries. The impact of formal training programs on decreasing the learning curve and improving outcomes, including safety, should also be studied. Finally, the cost-effectiveness of these devices has to be determined either by economic models or clinical trials measuring actual costs. Despite these seemingly large hurdles, one, if not more, of these technologies should meet these criteria and soon be used as an effective, durable, safe, and cost-effective treatment option for patients with GERD.
Fennerty
M Brian
MB
Division of Gastroenterology Oregon Health and Science University, 3181 SW Sam Jackson Park Road, Mail Code PV-310, Portland, OR 97239-3098, USA. fennerty@ohsu.edu
D002986:Clinical Trials as Topic; D003362:Cost-Benefit Analysis; D004724:Endoscopy / Q000379:methods*; D004943:Esophagogastric Junction / Q000473:pathology / Q000601:surgery*; D005764:Gastroesophageal Reflux / Q000601:surgery*; D006801:Humans; D012449:Safety; D016896:Treatment Outcome