Study Results
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View full resultsBasic Information
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COMPLETED
NA
58 participants
INTERVENTIONAL
2013-12-31
2017-11-30
Brief Summary
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Detailed Description
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We aim to achieve the following: determine the impact of laparoscopic anti-reflux surgery on change in FVC over 48 weeks in patients with IPF and abnormal GER; correlate the reduction in acid and non-acid reflux events with the change in FVC over 48 weeks in patients with IPF and abnormal GER; determine the safety of laparoscopic anti-reflux surgery in patients with IPF and abnormal GER; explore the impact of laparoscopic anti-reflux surgery on key secondary endpoints over 48 weeks in patients with IPF and abnormal GER; identify molecular markers of IPF disease activity and gastroesophageal reflux in biological samples from patients with IPF and abnormal GER.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
Subjects to receive standard anti-reflux treatment per clinical discretion
No interventions assigned to this group
Surgery
Subjects will receive laparoscopic fundoplication surgery
Surgery
Full fundoplication surgery for the treatment of abnormal GER
Interventions
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Surgery
Full fundoplication surgery for the treatment of abnormal GER
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Harold R Collard, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Ganesh Raghu, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Kevin J Anstrom, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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University of California
San Francisco, California, United States
University of Chicago
Chicago, Illinois, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Washington
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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References
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Raghu G, Pellegrini CA, Yow E, Flaherty KR, Meyer K, Noth I, Scholand MB, Cello J, Ho LA, Pipavath S, Lee JS, Lin J, Maloney J, Martinez FJ, Morrow E, Patti MG, Rogers S, Wolters PJ, Yates R, Anstrom KJ, Collard HR. Laparoscopic anti-reflux surgery for the treatment of idiopathic pulmonary fibrosis (WRAP-IPF): a multicentre, randomised, controlled phase 2 trial. Lancet Respir Med. 2018 Sep;6(9):707-714. doi: 10.1016/S2213-2600(18)30301-1. Epub 2018 Aug 9.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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Pro00049804
Identifier Type: -
Identifier Source: org_study_id