A clinical trial conducted in six medical centers in the United States has suggested that an operation, laparoscopic fundoplication, to treat abnormal acid gastroesophageal reflux in patients with idiopathic pulmonary fibrosis, or IPF, a fatal lung disease, may slow its progression.
A paper on the clinical trial was published in the medical journal The Lancet Respiratory Medicine.
Dr. Ganesh Raghu, a UW Medicine specialist in lung diseases with expertise in interstitial lung diseases, is the lead author of this pivotal study.
Raghu said, “It is clear that there is a strong association of abnormal acid reflux and IPF and the hypothesis that it may contribute to progression of disease is a longstanding one. But what is not clear is the evidence to date regarding the clinical impact of the acid gastroesophageal reflux and treatment as far as disease progression. We found that outcomes that are meaningful to patients with pulmonary fibrosis – acute exacerbation, hospitalization for respiratory problems, and deaths – were numerically fewer within the group who had surgery compared to the group that did not receive the surgery.
“Surgery was well tolerated by the patients and was determined to be safe. The overall totality of the results was favorable and warrants further study in larger patient populations and in multicenters,” he said.
Raghu is a professor of medicine, Division of Pulmonary, Critical Care and Sleep Medicine, at the University of Washington School of Medicine in Seattle and director of UW Medicine’s Center for Interstitial Lung Disease. Raghu and his surgical colleagues at University of Washington Medical Center have been investigating the role of abnormal acid gastroesophageal reflux in patients with pulmonary fibrosis for over 20 years.
Raghu said an earlier retrospective study at UW Medical Center had documented the safety of the procedure and a trend in slowing the disease progression in patients with IPF who underwent a fundoplication. The results of this prospective randomized clinical trial confirmed those observations and thus are reassuring and encouraging.
“It must be acknowledged that this study was done in highly selected centers of established experience and expertise in the management of idiopathic pulmonary fibrosis and surgery for gastroesophageal reflux, and thus, it is unknown if the safety of the surgical procedure in this patient population and the results reported in this study can be generalizable to the community setting,” Raghu cautioned.
“The results of this study confirm our previous observation that control of reflux with an operation appears to benefit selected patients with idiopathic pulmonary fibrosis,” said Dr. Carlos Pellegrini, lead surgeon in the study. Pellegrini is chief medical officer for UW Medicine and a professor of surgery at the UW School of Medicine.
The prognosis of IPF, a progressive disease involving both lungs in otherwise healthy adults (usually males over 6o years of age) is poor. The median survival following the diagnosis is 3 to 5 years. The lung tissue gets damaged, inflamed and scarred. The stiffened lung, as a consequence, makes breathing difficult. Oxygen does not get through the scar tissue in the lung to reach the blood stream in a sufficient manner. Patients suffer from shortness of breath and are limited in the activities they can do on a day-to day level.
Researchers have yet to determine the cause, while in a subgroup of patients with IPF, it may run in families. Only two medications are currently indicated and available for patients with IPF. These medications merely slow the disease progression.
“These results are interesting and open new research questions about the morbidity associated with idiopathic pulmonary fibrosis and the mechanisms of disease exacerbation,” said Dr. James Kiley, director, Division of Lung Diseases at the National Heart, Lung, and Blood Institute.
Source: University of Washington