Pneumatic Dilation Is Ineffective for Postfundoplication Dysphagia

Persistent dysphagia (ie, symptoms for more than 3 months) after fundoplication surgery is reported in up to 25% of patients. After anatomical causes of dysphagia have been ruled out, empiric dilation of the gastroesophageal junction (using a pneumatic balloon) is often performed to help with “stretching” the wrap. This approach is supported by data from retrospective cohort studies showing dysphagia improvement in more than 50% of treated patients. 

These authors conducted a prospective, multicenter (n=4), single-blind (patients), randomized, sham-controlled trial to evaluate the benefit of pneumatic dilation (PD) in patients with persistent dysphagia after a recent fundoplication surgery. In the PD group, a pneumatic balloon was inflated to 35 mm (1 minute at 5PSI and 1 minute at 8PSI), whereas in the sham group, the endoscope was placed in the stomach for 5 additional minutes with no dilation. A total of 42 patients were randomized to PD (n=21; 35% male; mean age, 53.7 years; mean Eckardt score, 7) or the sham group (n=21; 32% male; mean age, 56 years; mean Eckardt score, 6). 

There was no difference in success (defined as an Eckardt score <4 AND minimal reduction of 2 points in the score after 30 days) between the PD (33%) and the sham group (38%) (P=.747). Furthermore, there was no difference between the 2 groups in symptoms or quality of life, as evaluated by the Brief Esophageal Dysphagia Questionnaire, Reflux Disease Questionnaire, or the 36-item Short-Form Health Survey (all P>.1). On high-resolution manometry, there was no difference in 4-second integrated relaxation pressures between the 2 groups (10.5 mmHg [PD] vs 14.6 mmHg [sham]; P=.052). The use of barium esophagogram showed increased stasis in the PD group at 1 minute, but this difference resolved at 2 minutes and 5 minutes. There were no adverse events reported in either of the groups.