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A Normal 24-Hour Catheter Study in a Patient With Symptomatic GERD: Pursue the Diagnosis With a Wireless 48-Hour Capsule
Ashwin a. Kurian*, Katherine D. Freeman, Carrie Morrison, Reginald Bell
SurgOne Foregut Institute, Englewood, CO
Background:
Normal 24 hour ambulatory pH study is often treated by clinicians as being able to rule out GERD. Daily variations in esophageal acid exposure are well recognized but thought to be clinically insignificant. We studied the value of following a normal 24-hour ambulatory pH study with a wireless based 48-hour study in patients with a clinical suspicion of GERD.
Methods:
Patients with a normal 24-hr based pH study (total time pH < 4 of 4.4% or less) presenting for the evaluation of GERD between 04/2009 to 11/2013 were analyzed. All patients with a negative 24-hour pH test with a clinical suspicion of GERD underwent further testing with a 48-hour wireless study. Testing was performed off acid suppression in the same esophageal testing laboratory. Patients were divided into two groups: "+ve Capsule Group" and "-ve Capsule Group" (based on abnormal or normal esophageal acid exposure on the capsule based study). All p-values < 0.05 were considered significant.
Results:
108 patients with a clinical suspicion of GERD and a normal 24-hour pH study underwent further 48- hour testing via wireless capsule. Fifty patients (46%) had a positive wireless capsule test (total esophageal acid exposure of > 4.4% on either day or 48hr total). Eleven additional patients had either isolated abnormal upright or supine acid exposure on one of the two days (upright >6.1%; supine >2%). Hence a total of 61 patients (56.4%) had an abnormal acid exposure on prolonged testing. 24hr impedance/pH acid exposure in the +ve Capsule Group was significantly higher than the -ve Capsule Group: total acid (1.41 % vs 0.79%; p:0.001), upright acid (2.1% vs 1.2%; p:0.002), and recumbent acid (0.38% vs 0.14% p: 0.037).
Of the 61 patients with a positive capsule test, 21 patients (34%) underwent antireflux surgery: 11 laparoscopic partial fundoplications, 6 complete fundoplications, 3 transoral incisionless fundoplications and 1 LINX anti-reflux system. Eleven patients had typical GERD symptoms; the other 10 patients had primarily extraesophageal symptoms. Followup was available in 17 patients at a mean of 17 + 13 months. All patients reported a significant improvement in their GERD HRQOLs postoperatively (15 + 10 vs 3 + 5; p: 0.0001).
Conclusion:
This study reflects the clinically significant day to day variability in esophageal acid exposure in patients with GERD, and raises question about the negative predictive value of 24-hr catheter based reflux testing. Patients with normal esophageal acid exposure on a 24-hour catheter study have a 56 % probability of demonstrating abnormal esophageal acid exposure on a 48-hour wireless capsule study. Patients offered surgery based on further testing have significant improvements in their GERD symptomatology.
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