Weighing Risks and Benefits of Laparoscopic Anti-Reflux Surgery in Patients With Idiopathic Pulmonary Fibrosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 58
- Locations
- 5
- Primary Endpoint
- Forced Vital Capacity (FVC)
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Control
Subjects to receive standard anti-reflux treatment per clinical discretion
Surgery
Subjects will receive laparoscopic fundoplication surgery
Intervention: Surgery (Procedure)
Outcomes
Primary Outcomes
Forced Vital Capacity (FVC)
Time Frame: Baseline and 48 weeks
Change in FVC (in liters) between enrollment and 48 weeks.
Secondary Outcomes
- University of California San Diego (UCSD) Shortness of Breath Questionnaire (SOQB) Score(Baseline and 48 weeks)
- 6-minute Walk Distance(Baseline and 48 weeks)
- Change in Score From Baseline for Acid and Non-acid Reflux Events at 48 Weeks(Baseline and 48 weeks)
- Safety of Laparoscopic Anti-reflux Surgery(48 weeks)
- All-cause Mortality(48 weeks)
- Non-elective Hospitalization(Baseline and 48 weeks)
- Acute Exacerbations(Baseline and 48 weeks)
- St. George's Respiratory Questionnaire (SGRQ) Score(Baseline and 48 weeks)
- High-Resolution CT (HRCT) Fibrosis Score.(Baseline to 48 weeks)
- Cough Visual Analog Scale (VAS)(Baseline and 48 weeks)