Clinical trial NCT01982968: Treatment of IPF With Laparoscopic Anti-Reflux Surgery
Official title: Weighing Risks and Benefits of Laparoscopic Anti-Reflux Surgery in Patients With Idiopathic Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Pulmonary Fibrosis
Gastroesophageal Reflux
Keywords: Idiopathic pulmonary fibrosis
IPF
Gastroesophageal reflux
GER
GERD
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2013-11-13
Enrollment: 58
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Forced Vital Capacity (FVC)
timeFrame: Baseline and 48 weeks
Secondary outcomes:
measure: Change in Score From Baseline for Acid and Non-acid Reflux Events at 48 Weeks
timeFrame: Baseline and 48 weeks
measure: Safety of Laparoscopic Anti-reflux Surgery
timeFrame: 48 weeks
measure: All-cause Mortality
timeFrame: 48 weeks
measure: Non-elective Hospitalization
timeFrame: Baseline and 48 weeks
measure: Acute Exacerbations
timeFrame: Baseline and 48 weeks
measure: University of California San Diego (UCSD) Shortness of Breath Questionnaire (SOQB) Score
timeFrame: Baseline and 48 weeks
measure: St. George's Respiratory Questionnaire (SGRQ) Score
timeFrame: Baseline and 48 weeks
measure: 6-minute Walk Distance
timeFrame: Baseline and 48 weeks
measure: Cough Visual Analog Scale (VAS)
timeFrame: Baseline and 48 weeks
measure: High-Resolution CT (HRCT) Fibrosis Score.
timeFrame: Baseline to 48 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California
state: California
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of California, San Francisco
name: Harold R Collard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Ganesh Raghu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Kevin J Anstrom, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raghu G, Pellegrini CA, Yow E, Flaherty KR, Meyer K, Noth I, Scholand MB, Cello J, Ho LA, Pipavath S, Lee JS, Lin J, Maloney J, Martinez FJ, Morrow E, Patti MG, Rogers S, Wolters PJ, Yates R, Anstrom KJ, Collard HR. Laparoscopic anti-reflux surgery for the treatment of idiopathic pulmonary fibrosis (WRAP-IPF): a multicentre, randomised, controlled phase 2 trial. Lancet Respir Med. 2018 Sep;6(9):707-714. doi: 10.1016/S2213-2600(18)30301-1. Epub 2018 Aug 9.