Endoscopic, deep mural implantation of Enteryx for the treatment of GERD: 6-month follow-up of a multicenter trial.
OBJECTIVE
This prospective, multicenter, single-arm study evaluated the safety and efficacy of the endoscopic implantation of Enteryx, a biocompatible, non-biodegradable liquid polymer for the treatment of GERD.


METHODS
Eighty-five patients with heartburn symptoms responsive to proton pump inhibitor (PPI) use were enrolled. Inclusion requirements were HRQL score < or = 11 on PPI and > or = 20 off PPI, and 24-hour PH probe with > or = 5% total time at PH < or = 4. Patients with a hiatus hernia > 3 cm, grade 3 or 4 esophagitis, or esophageal motility disorder were excluded. Using a 4-mm needle tipped catheter during standard endoscopy, implants were made in 3-4 quadrants deep into the wall of the cardia. Use of PPI medications, pH-metry, manometry, GERD symptoms, and patient quality of life were assessed over a 6-month follow-up period.


RESULTS
At 6 months, PPI use was eliminated in 74% and reduced by > 50% in 10% of patients. The median HRQL score improved from 24.0 pre-implant (baseline off PPIs) to 4.0 at 6 months (p < 0.001). Mean total esophageal acid exposure time was 9.5% pretherapy and 6.7% at 6 months (p < 0.001). Mean LES length increased from 2.0 cm at baseline to 3.0 cm posttherapy (p = 0.003). There were no clinically serious adverse events. Transient mild-to-moderate chest pain commonly occurred after implantation.


CONCLUSIONS
The endoscopic implantation of Enteryx is a safe and effective therapy for eliminating or decreasing the need for PPI medications, improving GERD symptoms and patient quality of life, and decreasing esophageal acid exposure among patients suffering from GERD.
Johnson
David A
DA
Division of Gastroenterology, Eastern Virginia School of Medicine, Norfolk 23502, USA.
Ganz
Robert
R
Aisenberg
James
J
Cohen
Lawrence B
LB
Deviere
Jacques
J
Foley
T Raymond
TR
Haber
Gregory B
GB
Peters
Jeffrey H
JH
Lehman
Glen A
GA
D001704:Biopolymers / Q000008:administration & dosage / Q000627:therapeutic use*; D002299:Cardia; D004343:Drug Implants; D005260:Female; D005500:Follow-Up Studies; D005764:Gastroesophageal Reflux / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011145:Polyvinyls / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies; D054328:Proton Pump Inhibitors; D013997:Time Factors
D001704:Biopolymers; D004343:Drug Implants; D011145:Polyvinyls; D054328:Proton Pump Inhibitors; C020320:ethylene-vinyl alcohol copolymer