Endoluminal fundoplication (ELF) for GERD using EsophyX: a 12-month follow-up in a single-center experience.

BACKGROUND: Several endoscopic antireflux therapies have been proposed to reduce the need for chronic medical therapy or laparoscopic fundoplication for gastroesophageal reflux disease (GERD). Aim of this study was to evaluate the short- and mid-term clinical results of endoluminal fundoplication (ELF) with EsophyX. PATIENTS AND METHODS: From June 2006 to April 2008, 20 patients were enrolled in the study. All the ELFs were performed under general anesthesia. RESULTS: The mean duration of the procedure was 63 min (range 38-105). A median of 14 fasteners was placed. There were no major intraoperative complications. Two patients developed early complications and were treated conservatively. Four patients underwent, within the first year post-ELF, a laparoscopic fundoplication because of persistence of symptoms. One patient was lost to follow-up between 6 and 12 months. Among the other 15 patients who completed 12 months follow-up, the GERD health-related quality of life score decreased from a median of 40 to a median of 10 (p < 0.05), and seven patients were still off proton pump inhibitor. An improvement in esophageal acid exposure was recorded in 16.6% of patients, while in 66.7%, it worsened. CONCLUSIONS: ELF induced improvement of GERD symptoms and patients quality of life in a subgroup of patients with a reduced need for medication. However, it did not significantly change esophageal acid exposure in these patients. The need for revisional standard laparoscopic fundoplication was high.

Impact of long-term ranitidine and pantoprazole on accuracy of [13C]urea breath test.

No previous study has analyzed the impact of long-term antisecretory drugs on the precision of [13C]urea breath test (UBT). We assessed the rate of UBT conversion from positive to negative results during 60-day therapy with standard doses of ranitidine and pantoprazole. For this purpose, we recruited 60 dyspeptic patients with H. pylori infection ascertained on the basis of the concomitant results of CLO-test, histology, and UBT. Our patients were randomly assigned to receive ranitidine 300 mg at night or pantoprazole 40 mg in the morning for 60 days. UBT was performed at baseline and on days 14, 30, and 60, while patients were still taking antisecretory drugs. Patients with false-negative UBT on day 60 repeated the test every 3 days until conversion. After overnight fasting, duplicate breath test samples were taken from each patient before and 30 min after ingestion of 75 mg [13C]urea dissolved in 150 ml of 0.033 mol/liter citric acid. Four patients dropped out of the study. Both drugs induced similar false-negative UBTs on day 14 of dosing (P = 0.5). Afterwards, the three false-negative UBTs in the ranitidine group again became positive during therapy and particularly on day 30 of dosing. Of the four false-negative UBTs in the pantoprazole group at day 60, one became positive after 3 and three after 9 days of therapy cessation. Our findings show that the long-term use of ranitidine and pantoprazole at standard doses has different effects on the results of UBT. In the pantoprazole group patients again became positive within 3-9 days after stopping 60-day therapy, whereas in the ranitidine group patients reverted to positive on day 30 of dosing while they were still on treatment and this was likely due to development of tolerance. Therefore, patients taking pantoprazole need at least a 10-day withdrawal before UBT testing, while those taking ranitidine for at least 30 days can undergo UBT without the necessity of a wash-out period.