Weighing Risks and Benefits of Laparoscopic Anti-Reflux Surgery in Patients with Idiopathic Pulmonary Fibrosis (WRAP-IPF): A Phase II Clinical Trial.

Targeting confirmed idiopathic pulmonary fibrosis (IPF) and evidence of abnormal acid gastro-esophageal reflux (GER) by 24 hour impedance /pH testing in candidates. This is a multi-center, randomized study with treatment regimens of Laparoscopic anti-reflux surgery or standard of care over a period of 48 weeks.
The following hypothesis will be tested: Treatment with Laparoscopic anti-reflux surgery in subjects with idiopathic pulmonary fibrosis (IPF) and abnormal gastroesophageal (GER) reflux will slow the decline of forced vital capacity (FVC) over 48 weeks. It is further hypothesized Laparoscopic anti-reflux surgery will reduce the frequency of acid and non-acid reflux, will be safe and well tolerated, will improve symptoms and quality of life, and will reduce the incidence of acute exacerbation , hospitalization, disease progression and death.
High resolution CT imaging will be collected within 15 days of the screening visit. A single volumetric CT scan using a total lung capacity maneuver will be performed for research purposes unless the research subject has undergone clinical CT scanning and meets inclusion imaging criteria for the purpose of the study within the last 3 months. A second CT scan will be collected 48 weeks post randomization.
This is a NIH study with 5 sites in the U.S.