Treatment of IPF With Laparoscopic Anti-Reflux Surgery

Status:	Recruiting
Conditions:	Gastroesophageal Reflux Disease , Pulmonary
Therapuetic Areas:	Gastroenterology, Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	Any
Updated:	4/21/2016
Start Date:	December 2013
End Date:	November 2017

Weighing Risks and Benefits of Laparoscopic Anti-Reflux Surgery in Patients With Idiopathic Pulmonary Fibrosis

This study will test the hypothesis that treatment with laparoscopic anti-reflux surgery in
subjects with idiopathic pulmonary fibrosis (IPF) and abnormal gastroesophageal reflux (GER)
will slow the decline of forced vital capacity (FVC) over 48 weeks.

Inclusion Criteria:

- Confirmed diagnosis of idiopathic pulmonary fibrosis

- Abnormal GER on 24-hour pH monitoring (DeMeester score > 14.7)

- Able to provide informed consent

- Willing to undergo laparoscopic anti-reflux surgery

Exclusion Criteria:

- FVC < 50% predicted

- FEV1/FVC ratio < 0.65

- Resting room air PaO2 < 60mm Hg

- Unable to walk 50 meters on 6 minute walk test

- Acute respiratory illness in last 12 weeks

- Experimental medication for IPF in last 28 days

- Listed for lung transplantation at screening

- Unable to safely undergo surgery

- History of esophageal / bariatric / gastric surgery

- History of cancer (other than non-melanoma skin cancer) in last 3 years

- Pregnant at time of screening or enrollment

- Unable to obtain pre-authorized approval from a third party payer for surgery and
related costs

- Life expectancy < 48 weeks due to another illness

- BMI > 35

- Known severe pulmonary hypertension (mean pressure > 35 mm Jg on RHC; RVSP > 50 mm Hg
on ECHO)

We found this trial at

sites

University of Michigan

500 S State St
Ann Arbor, Michigan 48109

(734) 764-1817