Anti-reflux mucosectomy for gastroesophageal reflux disease: efficacy and mechanism of action.

A substantial part of patients with gastroesophageal reflux disease (GERD)
responds insufficiently to pharmacological therapy. In search of non-surgical
treatment methods in this patient group, a novel anti-reflux endoscopic
procedure - anti-reflux mucosectomy (ARMS) - has been developed. Although
previous studies suggest that ARMS is effective in reducing symptoms and total
acid exposure, the effects of the procedure on the number of reflux episodes
and the mechanisms through which reflux control is achieved have not been
investigated.

To investigate the efficacy and the mechanisms of action of an anti-reflux
mucosectomy in patients with gastroesophageal reflux disease.

A prospective therapeutic intervention study

All subjects will undergo ARMS. Reflux activity will be measured at baseline
and at 3 months follow-up with both ambulatory and prolonged postprandial
stationary pH-impedance measurements. Concomitantly, the occurrence of
transient lower esophageal sphincter relaxations (TLESRs) and the morphology of
the esophagogastric junction will be studied during a prolonged postprandial
stationary manometry. Furthermore, patients will undergo a follow-up endoscopy
3 months after ARMS.

All subjects will visit the AMC five times and will have to fill out
questionnaires on two separate occasions. Some investigations at baseline are
part of standard clinical work-up in patients with reflux symptoms. For the
purposes of this study, all patients will undergo two prolonged postprandial
recordings, one additional ambulatory pH-impedance measurement and an upper
endoscopy with distensibility measurements (EndoFLIP). ARMS appears to be an
efficacious and feasible procedure without significant intra- and postoperative
morbidity in uncomplicated reflux disease patients. Potential procedure-related
complications include esophageal stenosis, bleeding and perforation. The risks
of these complications to occur are likely to be minimal in *expert* hands and,
when these complications occur, they can usually be resolved using standard
endoscopic techniques. Patients will be closely monitored during the procedure
and follow-up. Endoscopy may cause mild discomfort, therefore sedation will be
offered. Manometry, EndoFLIP and pH-impedance studies are not associated with
additional risks. ARMS may improve reflux symptoms and esophagitis in
participating subjects. Participants will be compensated for their travel
expenses and the findings could help treat future patients with similar
complaints.