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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01982968
First received: November 6, 2013
Last updated: October 24, 2016
Last verified: October 2016
  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


Enrollment: 58
Study Start Date: December 2013
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (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

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  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
San Francisco, California, United States
United States, Illinois
University of Chicago
Chicago, Illinois, United States
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States
United States, Washington
University of Washington
Seattle, Washington, United States
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States
Sponsors and Collaborators
University of California, San Francisco
National Heart, Lung, and Blood Institute (NHLBI)
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

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: October 24, 2016
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:
Fibrosis
Gastroesophageal Reflux
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial

ClinicalTrials.gov processed this record on December 02, 2016