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Completed

NCT Number: NCT01982968

Treatment of IPF With Laparoscopic Anti-Reflux Surgery

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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Surgery

Procedure

Full fundoplication surgery for the treatment of abnormal GER

Other names: Nissen fundoplication, Laparoscopic fundoplication, Laparoscopic anti-reflux surgery

Primary outcomes

  1. Forced Vital Capacity (FVC)

    Time frame: Baseline and 48 weeks

    Change in FVC (in liters) between enrollment and 48 weeks.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: WRAP-IPF

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Nov 13, 2013
Registry last updated
Oct 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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