The use of laparoscopic antireflux surgery in patients with idiopathic pulmonary fibrosis (IPF) and abnormal acid gastroesophageal reflux (GER) is safe and well tolerated, according to the results of the phase 2, multicenter, randomized controlled, unblinded WRAP-IPF trial (ClinicalTrials.gov Identifier: NCT01982968) that were published in the Lancet Respiratory Medicine.
Investigators sought to determine whether normalization of abnormal acid GER with laparoscopic antireflux surgery reduced the rate of disease progression in patients with IPF. Patients with IPF and abnormal acid GER were recruited from 6 academic centers in the United States, with a coordinating center at the Duke Clinical Research Institute in Durham, North Carolina.
Individuals with IPF, abnormal acid GER (DeMeester score ≥14.7, measured with 24-hour pH monitoring), and preserved forced vital capacity (FVC) were enrolled in the trial. Concomitant treatment with nintedanib and pirfenidone was permitted. The primary study end point was change in FVC from randomization to week 48 in the intention-to-treat population, with mixed-effects models for repeated measures.
A total of 72 patients were screened between June 1, 2014, and September 30, 2016, with 58 patients randomly assigned to receive surgery (n=29) or no surgery (n=29). Overall, 27 patients in the surgery group and 20 patients in the no-surgery group had an FVC measurement at 48 weeks (P =.041). Intention-to-treat analysis that was adjusted for baseline antifibrotic use demonstrated the adjusted rate of change in FVC over the course of 48 weeks to be −0.05 L (95% CI, −0.15 to 0.05 L) in the surgery group vs −0.13 L (95% CI, −0.23 to −0.02 L) in the nonsurgery group (P =.28). Although acute exacerbation, respiratory-related hospitalization, and death were less common in the surgery group, the differences were not statistically significant.
Overall, dysphagia (29% [8 of 28]) and abdominal distension (14% [4 of 28]) were the most commonly reported adverse events after surgery. One death was reported in the surgery group and 4 deaths in the nonsurgery group.
The researchers concluded that although the study results showed the safety and tolerability of laparoscopic antireflux surgery performed in patients with IPF and abnormal acid GER, further investigation in larger, well-powered, more generalizable studies is warranted to confirm the effect of antireflux surgery on disease progression in this population.
Raghu G, Pellegrini CA, Yow E, et al. Laparoscopic anti-reflux surgery for the treatment of idiopathic pulmonary fibrosis (WRAP-IPF): a multicentre, randomised, controlled phase 2 trial [published online August 9, 2018]. Lancet Respir Med. doi:10.1016/S2213-2600(18)30301-1