Raghu G, et al. - In the WRAP-IPF trial, researchers investigated the impact of treatment of abnormal acid gastro-oesophageal reflux (GER) with laparoscopic anti-reflux surgery on the rate of idiopathic pulmonary fibrosis (IPF) progression. Laparoscopic anti-reflux surgery proved safe and was well tolerated among patients with IPF and abnormal acid GER.

Methods

• Researchers performed the WRAP-IPF trial, which was a randomised controlled trial of laparoscopic anti-reflux surgery in patients with IPF and abnormal acid GER; the patients were recruited from six academic centres in the USA.
• Patients with IPF, abnormal acid GER (DeMeester score of ≥14·7; measured by 24-h pH monitoring) and preserved forced vital capacity (FVC) were enrolled.
• Patients were excluded if they had FVC below 50% predicted, a FEV1/FVC ratio of less than 0·65, a history of acute respiratory illness in the past 12 weeks, a body-mass index greater than 35, and known severe pulmonary hypertension.
• They allowed concomitant therapy with nintedanib and pirfenidone.
• Change in FVC from randomisation to week 48 was assessed as the primary endpoint, in the intention-to-treat population with mixed-effects models for repeated measures. 

Results

• Seventy two patients were screened from June 1, 2014, to Sept 30, 2016, of these, 58 were assigned to receive surgery (n=29) or no surgery (n=29).
• An FVC measurement at 48 weeks was performed in 27 patients in the surgery group and 20 patients in the no surgery group (p=0·041).
• The adjusted rate of change in FVC over 48 weeks was −0·05 L (95% CI −0·15 to 0·05) in the surgery group and −0·13 L (−0·23 to −0·02) in the non-surgery group in the intention-to-treat analysis adjusted for baseline anti-fibrotic(p=0·28).
• The surgery group had less frequent acute exacerbation, respiratory-related hospitalisation, and death.
• The most common adverse events after surgery included dysphagia (eight [29%] of 28) and abdominal distention (four [14%] of 28).
• One death in the surgery group and four deaths in the non-surgery group were reported.