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Summary

at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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.

Official Title

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

Keywords

Idiopathic Pulmonary Fibrosis Gastroesophageal Reflux IPF GER GERD

Eligibility

You can join if…

  • 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

You CAN'T join if...

  • 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)

Locations

  • University of Washington
    Seattle, Washington, United States
  • University of Wisconsin
    Madison, Wisconsin, United States
  • University of Chicago
    Chicago, Illinois, United States
  • University of Michigan
    Ann Arbor, Michigan, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT01982968
Phase
Phase 2
Lead Scientist
Harold Collard
Study Type
Interventional
Last Updated
October 1, 2016