Pneumatic vs sham dilation not more effective for dysphagia after antireflux surgery
Click Here to Manage Email Alerts
Pneumatic dilation, or PD, with a 35-mm balloon compared with sham dilation was not superior for the treatment of persistent dysphagia after fundoplication, according to a study published in Gut.
“In patients with persistent dysphagia after laparoscopic fundoplication, pneumatic dilation is not more effective than sham dilation,” Jeroen M. Schuitenmaker, MD, from the department of gastroenterology and hepatology, Amsterdam Gastroenterology and Metabolism, Amsterdam UMC and colleagues wrote. “Thus, there is no rationale to perform PD in patients without any objective metric of obstruction or anatomical defect. Other treatment options, such as modulation of esophageal sensitivity, should be explored.”
Schuitenmaker and colleagues performed a multicenter, single-blind randomized sham-controlled trial of 42 patients with persistent dysphagia after laparoscopic fundoplication. Investigators assigned patients with an Eckardt symptom score of 4 to either a PD using a 35-mm balloon or sham dilation.
Treatment success served as the primary outcome, defined as an Eckardt score less than 4 and a minimal decrease of 2 points after 30 days. Other outcomes included change in stasis on timed barium esophagogram; change in high-resolution manometry parameters; and questionnaires on quality of life, reflux and dysphagia symptoms.
Results from the intention-to-treat analysis showed after 30 days, the success rates of PD and sham dilation were similar (risk difference –4.7%; 95% CI –33.7% to 24.2%; P = .747). Investigators noted no difference in the change of stasis on the timed barium esophagogram after 2 minutes (PD vs sham: median 0.0 cm, p25- p75 range 0.0-4.3 cm vs. median 0.0 cm, p25-p75 range 0.0-0.0; P = .122). In addition, there was no difference in the change in lower esophageal sphincter relaxation pressure (PD vs. sham: 10.54 ± 6.25 vs. 14.60 ± 6.17 mm Hg; P = .052). The groups were not significantly different with regard to quality of life, reflux and dysphagia symptoms.
“Although there are some limitations, we believe that this randomized single-blind, sham-controlled study has proven the lack of efficacy of pneumatic dilation for this group of patients without an objective metric of obstruction or anatomical defect,” the authors wrote.
Collapse
Read more about
Click Here to Manage Email Alerts