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

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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
5
sites
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Kevin Flaherty, MD
University of Michigan The University of Michigan was founded in 1817 as one of the...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Imre Noth, MD
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Ganesh Raghu, MD
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Seattle, WA
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Madison, Wisconsin 53792
(608) 263-2400
Principal Investigator: Keith Meyer, MD
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Madison, WI
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San Francisco, California 94143
Principal Investigator: Harold Collard, MD
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San Francisco, CA
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