BACKGROUND AND STUDY AIMS: The aim of the study was to evaluate the safety, feasibility, and efficacy of transnasal placement of the Medtronic Bravo capsule for wireless esophageal pH monitoring. PATIENTS AND METHODS: Forty patients with symptomatic gastroesophageal reflux disease were prospectively evaluated. All patients underwent upper gastrointestinal endoscopy and esophageal manometry. The Bravo capsule was then introduced transnasally and released 5 cm above the upper margin of the lower esophageal sphincter. Serial radiographs were performed weekly until capsule release. RESULTS: Of the 40 patients who were evaluated, 38 (95 %) were eligible to undergo the procedure. Transnasal placement proved impossible in one patient (2.5 %). Overall, a total of 39 procedures were performed in 38 patients (the procedure was repeated in one patient because of accidental intragastric fixation). Esophageal placement was successful in 36/39 procedures (92.3 %). The mean duration of the procedure was 10 minutes (range 5 - 16 minutes). Adverse events were noted in five of the 39 procedures (12.8 %), mild epistaxis in two patients (5.1 %) and pharyngeal irritation in three patients (7.7 %). After the procedure, a slight "foreign body" sensation was reported by 20 of the 36 patients (55.5 %) who had undergone successful esophageal placement; two patients (5.5 %) experienced severe retrosternal pain necessitating endoscopic removal of the capsule. At the end of the study, 34 of the 38 patients (89.5 %) stated that they would be willing to undergo the test again if necessary. CONCLUSIONS: Transnasal placement of the Bravo pH capsule is safe, well tolerated, does not require sedation, and avoids endoscopy and its complications.
BACKGROUND AND STUDY AIMS: The aim of the study was to evaluate the safety, feasibility, and efficacy of transnasal placement of the Medtronic Bravo capsule for wireless esophageal pH monitoring. PATIENTS AND METHODS: Forty patients with symptomatic gastroesophageal reflux disease were prospectively evaluated. All patients underwent upper gastrointestinal endoscopy and esophageal manometry. The Bravo capsule was then introduced transnasally and released 5 cm above the upper margin of the lower esophageal sphincter. Serial radiographs were performed weekly until capsule release. RESULTS: Of the 40 patients who were evaluated, 38 (95 %) were eligible to undergo the procedure. Transnasal placement proved impossible in one patient (2.5 %). Overall, a total of 39 procedures were performed in 38 patients (the procedure was repeated in one patient because of accidental intragastric fixation). Esophageal placement was successful in 36/39 procedures (92.3 %). The mean duration of the procedure was 10 minutes (range 5 - 16 minutes). Adverse events were noted in five of the 39 procedures (12.8 %), mild epistaxis in two patients (5.1 %) and pharyngeal irritation in three patients (7.7 %). After the procedure, a slight "foreign body" sensation was reported by 20 of the 36 patients (55.5 %) who had undergone successful esophageal placement; two patients (5.5 %) experienced severe retrosternal pain necessitating endoscopic removal of the capsule. At the end of the study, 34 of the 38 patients (89.5 %) stated that they would be willing to undergo the test again if necessary. CONCLUSIONS: Transnasal placement of the Bravo pH capsule is safe, well tolerated, does not require sedation, and avoids endoscopy and its complications.
Authors: Emile P Chen; Kelly M Mahar Doan; Samm Portelli; Robert Coatney; Vernal Vaden; Wei Shi Journal: Pharm Res Date: 2007-07-06 Impact factor: 4.200