Transoral, flexible endoscopic suturing for treatment of GERD: a multicenter trial.
BACKGROUND
A totally transoral outpatient procedure for the treatment of GERD would be appealing.


METHODS
A multicenter trial was initiated that included 64 patients with GERD treated with an endoscopic suturing device. Inclusion criteria were 3 or more heartburn episodes per week while not taking medication, dependency on antisecretory medicine, and documented acid reflux by pH monitoring. Exclusion criteria were dysphagia, grade 3 or 4 esophagitis, obesity, and hiatus hernia greater than 2 cm in length. Patients underwent manometry, endoscopy, 24-hour pH monitoring, and symptom severity scoring before and after the procedure. Patients were randomized to a linear or circumferential plication configuration. Adverse procedural events were recorded.


RESULTS
Mean 6-month symptom score changes demonstrated procedural efficacy. Heartburn severity and frequency as well as regurgitation all improved (p > 0.0001 for each). Twenty-four-hour pH monitoring showed improvement in number of episodes below pH of 4 at 3 and 6 months (p < 0.0007 and 0.0002) and percentage of total time the pH was less than 4 at 6 months (p < 0.011). Plication configuration did not affect symptoms or pH monitoring results. One patient had a self-contained suture perforation that was successfully treated with antibiotics.


CONCLUSIONS
Endoscopic gastroplasty is safe. It is associated with reduced symptoms and medication use at 6 month follow-up in patients with uncomplicated GERD.
Department of Surgery, Creighton University, Omaha, Nebraska 68131, USA.
C J
CJ
Filipi
G A
GA
Lehman
R I
RI
Rothstein
I
I
Raijman
G V
GV
Stiegmann
J P
JP
Waring
J G
JG
Hunter
C J
CJ
Gostout
S A
SA
Edmundowicz
D P
DP
Dunne
P A
PA
Watson
D A
DA
Cornet
D005764:Gastroesophageal Reflux / Q000517:prevention & control / Q000601:surgery*; D015391:Gastroplasty / Q000009:adverse effects / Q000379:methods*; D005773:Gastroscopy / Q000379:methods*; D006356:Heartburn / Q000175:diagnosis; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008365:Manometry; D011788:Quality of Life; D013536:Suture Techniques