Researchers investigated the feasibility, safety, and efficacy of radio-frequency energy delivery to the gastroesophageal junction for the treatment of gastroesophageal reflux disease (GERD).
They reported their findings in April's Gastrointestinal Endoscopy.
47 patients (32 men) with classic symptoms of GERD, a daily anti-secretory medication requirement, and at least partial symptom response to drugs were enrolled.
All patients had pathologic esophageal acid exposure by 24-hour pH study, a 2-cm or smaller hiatal hernia, Grade 2 or less esophagitis, and no significant dysmotility or dysphagia.
Radio-frequency energy was delivered with a catheter and thermocouple-controlled generator to create submucosal thermal lesions in the muscle of the gastroesophageal junction.
GERD symptoms and quality of life were assessed at 0, 1, 4, and 6 months with the short-form health survey. Medication use, endoscopic findings, esophageal acid exposure, and motility were assessed at 0 and 6 months.
At 6 months the investigators found there were improvements in the median heartburn score (4 to 1), GERD score (26 to 7), satisfaction (1 to 4), and esophageal acid exposure (11.7% to 4.8%). There were also improvements in mental (46.2 to 55.5) and physical (41.1 to 51.9) health survey scores.
Esophagitis was present in 25 patients before treatment (15 Grade 1 and 10 Grade 2) and 8 at 6 months (4 grade 1 and 4 grade 2).
At 6 months, 87% of patients no longer required treatment with a proton pump inhibitor.
|After treatment there were improvements in:|
- Esophageal acid exposure
There was no significant change in median lower esophageal sphincter pressure (14.0 to 12.0 mm Hg), peristaltic amplitude (64 to 66 mm Hg), or lower esophageal sphincter length (3.0 to 3.0).
The researchers found that there were 3 self-limited complications. These were fever for 24 hours, odynophagia lasting for 5 days, and a linear mucosal injury that was healed after 3 weeks.
Dr George Triadafilopoulos, from Palo Alto, California, concluded, "Radio-frequency energy delivery significantly improved GERD symptoms, quality of life, and esophageal acid exposure.
"It also eliminated the need for anti-secretory medication in the majority of patients with a heterogeneous spectrum of clinical disease severity, but with minimal active esophagitis or hiatal hernia."