Treatment of IPF With Laparoscopic Anti-Reflux Surgery

Idiopathic Pulmonary Fibrosis Clinical Trial

— WRAP-IPF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01982968
• Other study ID #: Pro00049804
• Secondary ID: 1UM1HL119089
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: November 2017

Study information

• Verified date: September 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Fibrosis
• Gastroesophageal Reflux
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Procedure:
• Surgery
Full fundoplication surgery for the treatment of abnormal GER

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Chicago	Chicago	Illinois
United States	University of Wisconsin	Madison	Wisconsin
United States	University of California	San Francisco	California
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 th — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced Vital Capacity (FVC)	Change in FVC (in liters) between enrollment and 48 weeks.	Baseline and 48 weeks
Secondary	Change in Score From Baseline for Acid and Non-acid Reflux Events at 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).	Baseline and 48 weeks
Secondary	Safety of Laparoscopic Anti-reflux Surgery	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.	48 weeks
Secondary	All-cause Mortality	Impact of anti-reflux surgery on all-cause mortality from enrollment to 48 weeks	48 weeks
Secondary	Non-elective Hospitalization	Impact on non-elective hospitalizations from baseline to 48 weeks.	Baseline and 48 weeks
Secondary	Acute Exacerbations	Impact on acute exacerbations of IPF from baseline to week 48.	Baseline and 48 weeks
Secondary	University of California San Diego (UCSD) Shortness of Breath Questionnaire (SOQB) Score	Change in UCSD SOQB score from baseline to week 48. The score range is 0-120. Higher scores indicate higher breathlessness.	Baseline and 48 weeks
Secondary	St. George's Respiratory Questionnaire (SGRQ) Score	Change in SGRQ score from baseline to week 48. The score range is 0-100. Higher scores indicate more limitations.	Baseline and 48 weeks
Secondary	6-minute Walk Distance	Change in 6-minute walk distance from baseline to week 48	Baseline and 48 weeks
Secondary	Cough Visual Analog Scale (VAS)	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.	Baseline and 48 weeks
Secondary	High-Resolution CT (HRCT) Fibrosis Score.	Change in HRCT fibrosis score from baseline to week 48. HRCT Fibrosis score is calculated as a percentage. Higher percentage indicates more fibrosis.	Baseline to 48 weeks