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.
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
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5801 South Ellis Avenue
Chicago, Illinois 60637
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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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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500 S State St
Ann Arbor, Michigan 48109
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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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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