A novel endoscopic full-thickness plicator for the treatment of GERD: A pilot study.
BACKGROUND
The novel full-thickness plication described in this study was designed to inhibit gastroesophageal reflux by placement of a transmural plication near the gastroesophageal junction under direct endoscopic visualization. The resulting serosa-to-serosa tissue union is thought to accentuate and restore the valvular mechanism of the gastroesophageal junction. The aim of this study was to assess the safety and feasibility of endoscopic full-thickness plication for the treatment of patients with GERD symptoms.


METHODS
A pilot study was performed in patients with chronic heartburn and pathologic reflux requiring maintenance antisecretory therapy. A single full-thickness plication was placed in the gastric cardia within 1 to 2 cm of the gastroesophageal junction. The primary end points of the study were procedure safety and feasibility, as well as long-term durability of the full-thickness tissue fixation. Secondary end points included medication use and the GERD-Health Related Quality of Life questionnaire and Gastrointestinal Symptom Rating Scale.


RESULTS
Full-thickness plication was performed successfully in 6 of 7 patients, with one procedure aborted because of difficulty in sedating the patient. Mean procedure time was 21 minutes. Mild epigastric pain was reported by two patients and difficulty with eructation by one patient; all symptoms resolved spontaneously within 7 days of the procedure. Endoscopy at 6 months revealed an intact plication in all patients. At 1 year after the procedure, patients reported sustained reduction in heartburn scores. One patient, who did not experience significant relief of symptoms, ultimately underwent successful laparoscopic Nissen fundoplication at 6 months after the procedure. At 1 year after the procedure, 3 of 5 patients were not taking anti-GERD medications.


CONCLUSIONS
Endoscopic full-thickness plication is feasible, safe and, in this pilot study, appeared to reduce symptoms and medication use associated with GERD.
Harvard Medical School, Boston, Massachusetts, USA.
Ram
R
Chuttani
Randhir
R
Sud
Gopal
G
Sachdev
Rajesh
R
Puri
Richard
R
Kozarek
Gregory
G
Haber
Douglas
D
Pleskow
Mohammed
M
Zaman
Anthony
A
Lembo
D000328:Adult; D002299:Cardia / Q000601:surgery; D004945:Esophagoscopy / Q000379:methods*; D005240:Feasibility Studies; D005764:Gastroesophageal Reflux / Q000601:surgery*; D006801:Humans; D008297:Male; D008365:Manometry; D010865:Pilot Projects; D012449:Safety