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A novel endoscopic full-thickness plicator for treatment of GERD: an animal model study
Ram Chuttani1, Richard Kozarek, Jonathan Critchlow
1Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, USA.
Background:
This study was designed to demonstrate the efficacy and safety of a novel endoscopic full-thickness plication device for the treatment of GERD.
Methods:
Gastric pressures and reflux from the gastroesophageal junction were measured in 20 excised pig stomachs before and after full-thickness plication within 1 cm of the gastroesophageal junction. Endoscopic full-thickness plication was performed on 11 live mini-swine that were subsequently observed for up to 12 weeks.
Observations:
Full-thickness plication significantly increased the mean intragastric pressure at which gastroesophageal reflux occurred. No complication, death, or sign of infection or tissue damage was noted by endoscopic observation or inspection of excised tissue at up to 12 weeks' follow-up.
Conclusions:
These studies in the ex vivo porcine model and live pigs suggest that full-thickness plication is effective and safe.