Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Treatment of IPF With Laparoscopic Anti-Reflux Surgery (WRAP-IPF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of California, San Francisco
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01982968
First received: November 6, 2013
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Idiopathic Pulmonary Fibrosis
Gastroesophageal Reflux
Procedure: Surgery
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Weighing Risks and Benefits of Laparoscopic Anti-Reflux Surgery in Patients With Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Forced vital capacity (FVC) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Decline in FVC (in liters) between enrollment and 48 weeks.


Secondary Outcome Measures:
  • Acid and non-acid reflux events [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Reduction in acid and non-acid reflux events from enrollment to week 48

  • Safety of laparoscopic anti-reflux surgery [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    Overall safety of laparoscopic anti-reflux surgery in patients with IPF and abnormal GER

  • All-cause mortality [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Impact of anti-reflux surgery on all-cause mortality from enrollment to 48 weeks

  • Non-elective hospitalization [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Impact on non-elective hospitalizations from enrollment to 48 weeks.

  • Acute exacerbations [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Impact on acute exacerbations of IPF from enrollment to week 48.

  • UCSD SOQB score [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Change in UCSD Shortness of Breath Questionnaire score from enrollment to week 48

  • SGRQ Score [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Change in St. George's Respiratory Questionnaire score from enrollment to week 48

  • 6-minute walk distance [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Change in 6-minute walk distance from enrollment to week 48

  • Cough VAS [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Change in cough visual analog scale (VAS) from enrollment to week 48

  • HRCT fibrosis score [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Change in HRCT fibrosis score from enrollment to week 48


Estimated Enrollment: 58
Study Start Date: December 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Subjects to receive standard anti-reflux treatment per clinical discretion
Active Comparator: Surgery
Subjects will receive laparoscopic fundoplication surgery
Procedure: Surgery
Full fundoplication surgery for the treatment of abnormal GER
Other Names:
  • Nissen fundoplication
  • Laparoscopic fundoplication
  • Laparoscopic anti-reflux surgery

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of idiopathic pulmonary fibrosis
  • Abnormal GER on 24-hour impedance/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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01982968

Locations
United States, California
University of California Recruiting
San Francisco, California, United States
Contact: Archer Eller       archer.eller@uscf.edu   
Principal Investigator: Harold Collard, MD         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States
Contact: Spring Maleckar       smalecka@medicine.bsd.uchicago.edu   
Contact: Maggie Holly       mholly@medicine.bsd.chicago.edu   
Principal Investigator: Imre Noth, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States
Contact: Deb Dahlgren       ddahlgre@med.umich.edu   
Contact: Candace Flaherty       clfah@med.umich.edu   
Principal Investigator: Kevin Flaherty, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States
Contact: Angela Snydsman       asnydsma@u.washington.edu   
Principal Investigator: Ganesh Raghu, MD         
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States
Contact: Mary Jo Jackson       mmj@medicine.wisc.edu   
Principal Investigator: Keith Meyer, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Harold R Collard, MD University of California, San Francisco
Principal Investigator: Ganesh Raghu, MD University of Washington
Principal Investigator: Kevin J Anstrom, PhD Duke University
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01982968     History of Changes
Other Study ID Numbers: Pro00049804, 1UM1HL119089
Study First Received: November 6, 2013
Last Updated: September 4, 2014
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by University of California, San Francisco:
Idiopathic pulmonary fibrosis
IPF
Gastroesophageal reflux
GER
GERD

Additional relevant MeSH terms:
Gastroesophageal Reflux
Fibrosis
Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases
Lung Diseases, Interstitial
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 27, 2014