Treatment of IPF With Laparoscopic Anti-Reflux Surgery

Not Applicable

Completed

• Conditions: Gastroesophageal Reflux; Idiopathic Pulmonary Fibrosis
• Interventions: Procedure: Surgery

• Registration Number: NCT01982968
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2013-11-06
• Study First Submitted QC: 2013-11-06
• Study First Posted: 2013-11-13
• Study Start: 2013-12
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Results First Submitted: 2018-12-07
• Status Verified: 2021-09
• Results First Submitted QC: 2021-09-27
• Last Update Submitted: 2021-09-27
• Results First Posted: 2021-10-25
• Last Update Posted: 2021-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery	Surgery	Subjects will receive laparoscopic fundoplication surgery

Primary Outcome Measures

Name	Time	Method
Forced Vital Capacity (FVC)	Baseline and 48 weeks	Change in FVC (in liters) between enrollment and 48 weeks.

Secondary Outcome Measures

Name	Time	Method
University of California San Diego (UCSD) Shortness of Breath Questionnaire (SOQB) Score	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.
6-minute Walk Distance	Baseline and 48 weeks	Change in 6-minute walk distance from baseline to week 48
Change in Score From Baseline for Acid and Non-acid Reflux Events at 48 Weeks	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).
Safety of Laparoscopic Anti-reflux Surgery	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.
All-cause Mortality	48 weeks	Impact of anti-reflux surgery on all-cause mortality from enrollment to 48 weeks
Non-elective Hospitalization	Baseline and 48 weeks	Impact on non-elective hospitalizations from baseline to 48 weeks.
Acute Exacerbations	Baseline and 48 weeks	Impact on acute exacerbations of IPF from baseline to week 48.
St. George's Respiratory Questionnaire (SGRQ) Score	Baseline and 48 weeks	Change in SGRQ score from baseline to week 48. The score range is 0-100. Higher scores indicate more limitations.
High-Resolution CT (HRCT) Fibrosis Score.	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.
Cough Visual Analog Scale (VAS)	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.

Trial Locations

Locations (5)

University of Chicago; 🇺🇸 Chicago, Illinois, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States

University of California; 🇺🇸 San Francisco, California, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States