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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01982968
Recruitment Status : Completed
First Posted : November 13, 2013
Results First Posted : October 25, 2021
Last Update Posted : October 25, 2021
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Gastroesophageal Reflux Procedure: Surgery Not Applicable

Detailed Description:

This protocol proposes to test the following hypothesis: Treatment with laparoscopic anti-reflux surgery in subjects with idiopathic pulmonary fibrosis (IPF) and abnormal gastroesophageal (GER) reflux will slow the decline of forced vital capacity (FVC) over 48 weeks. This study will randomize approximately 58 subjects with IPF and abnormal acid reflux on 24-hour impedance / pH monitoring to laparoscopic anti-reflux surgery or standard care (randomization ratio 1:1). Subjects will be followed for 48 weeks or until the time of lung transplantation or death.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Weighing Risks and Benefits of Laparoscopic Anti-Reflux Surgery in Patients With Idiopathic Pulmonary Fibrosis
Study Start Date : December 2013
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Forced Vital Capacity (FVC) [ Time Frame: Baseline and 48 weeks ]
    Change in FVC (in liters) between enrollment and 48 weeks.


Secondary Outcome Measures :
  1. Change in Score From Baseline for Acid and Non-acid Reflux Events at 48 Weeks [ Time Frame: Baseline and 48 weeks ]
    Change in acid and non-acid reflux events from baseline to week 48. All subjects answered questions related to their reflux using a Likert scale (0 = never, 1 =occasionally, 2 = sometimes, 3 = often, 4 = always).

  2. Safety of Laparoscopic Anti-reflux Surgery [ Time Frame: 48 weeks ]
    Overall safety of laparoscopic anti-reflux surgery in patients with IPF and abnormal GER as measured by number of participants who experienced death, serious adverse event, or other (not including serious) adverse event. See Adverse Events section for additional details.

  3. All-cause Mortality [ Time Frame: 48 weeks ]
    Impact of anti-reflux surgery on all-cause mortality from enrollment to 48 weeks

  4. Non-elective Hospitalization [ Time Frame: Baseline and 48 weeks ]
    Impact on non-elective hospitalizations from baseline to 48 weeks.

  5. Acute Exacerbations [ Time Frame: Baseline and 48 weeks ]
    Impact on acute exacerbations of IPF from baseline to week 48.

  6. University of California San Diego (UCSD) Shortness of Breath Questionnaire (SOQB) Score [ Time Frame: Baseline and 48 weeks ]
    Change in UCSD SOQB score from baseline to week 48. The score range is 0-120. Higher scores indicate higher breathlessness.

  7. St. George's Respiratory Questionnaire (SGRQ) Score [ Time Frame: Baseline and 48 weeks ]
    Change in SGRQ score from baseline to week 48. The score range is 0-100. Higher scores indicate more limitations.

  8. 6-minute Walk Distance [ Time Frame: Baseline and 48 weeks ]
    Change in 6-minute walk distance from baseline to week 48

  9. Cough Visual Analog Scale (VAS) [ Time Frame: Baseline and 48 weeks ]
    Change in VAS from baseline to week 48. The scale range is 1-100. Lower scores indicate no cough and 100 indicates the worst cough.

  10. High-Resolution CT (HRCT) Fibrosis Score. [ Time Frame: Baseline to 48 weeks ]
    Change in HRCT fibrosis score from baseline to week 48. HRCT Fibrosis score is calculated as a percentage. Higher percentage indicates more fibrosis.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01982968


Locations
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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
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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
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
Informed Consent Form  [PDF] July 19, 2016

Publications of Results:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01982968    
Other Study ID Numbers: Pro00049804
1UM1HL119089 ( U.S. NIH Grant/Contract )
First Posted: November 13, 2013    Key Record Dates
Results First Posted: October 25, 2021
Last Update Posted: October 25, 2021
Last Verified: September 2021
Keywords provided by University of California, San Francisco:
Idiopathic pulmonary fibrosis
IPF
Gastroesophageal reflux
GER
GERD
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases