Weighing Risks and Benefits of Laparoscopic Anti-Reflux Surgery in Patients With Idiopathic Pulmonary Fibrosis (WRAP-IPF)
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December 2013 – November 2017
Dataset(s) Last Updated
August 29, 2019
Clinical Trial URLs
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Commercial Use Data Restrictions No
Data Restrictions Based On Area Of Research No
To determine if the reduction of abnormal gastro-esophageal reflux (GER) with laparoscopic anti-reflux surgery will slow the progression of idiopathic pulmonary fibrosis (IPF) as measured by forced vital capacity (FVC).
Idiopathic pulmonary fibrosis (IPF) is a chronic progressive lung disease of unknown cause and increasing prevalence in the United States. Aside from lung transplantation, which approximately only 1% of patients will receive, there is no FDA-approved therapy. Abnormal acid gastro-esophageal reflux (GER) has been well described in patients with IPF and is thought to play a role in the progression of the disease. The several retrospective cohort studies that have assessed the association of anti-acid therapies for GER with clinical outcomes in IPF have had inconsistent results.
Eligible participants had a confirmed diagnosis of idiopathic pulmonary fibrosis and abnormal acid GER (DeMeester score of ≥14.7; measured by 24-hour pH monitoring). Exclusion criteria included FVC below 50% predicted, FEV₁/FVC ratio of less than 0.65, a room air partial pressure of oxygen in the blood of less than 60 mm Hg, a 6-min walk distance of less than 50 m, history of acute respiratory illness in the past 12 weeks, a body-mass index greater than 35, inability to safely undergo laparoscopic anti-reflux surgery, known severe pulmonary hypertension, and listing for lung transplantation. A total of 58 patients were enrolled at six academic centers in the United States, with 29 randomized to the surgery group and 29 randomized to the no surgery group. 28 patients in the surgery group received surgery and 27 patients completed the study. 2 patients in the no surgery group received surgery after week twenty-four and 21 completed the study.
The WRAP-IPF trial was a multicenter, unblinded randomized clinical trial with patients randomized to either laparoscopic anti-reflux surgery or no surgery. Participants in the no surgery group had the option of receiving laparoscopic anti-reflux surgery from 24 weeks after randomization if their clinician deemed it medically necessary. Medications for acid GER were allowed in both groups if the clinician felt it was necessary.
Participants were followed up from time of randomization to 52 weeks. All participants had study visits at baseline, 12, 24, 36, and 48 weeks, during which spirometry, 6-min walk testing, and patient-related outcome assessments were done. Participants in the surgery group had clinical visits for preoperative evaluation, laparoscopic anti-reflux surgery, and postoperative management as clinically indicated. Surgery participants additionally underwent repeat 24-hour pH testing at 24 weeks to assess the efficacy of the surgery. All participants were contacted by telephone for safety assessments at weeks 4, 8, 16, 20, 28, 32, 40, 44, and 52. All participants completed an exploratory questionnaire on reflux symptoms at baseline and 48 weeks.
The primary endpoint was change in FVC from randomization (baseline) to 48 weeks. Secondary endpoints included acute exacerbation, non-elective hospitalization (both all-cause and respiratory-related), death, change in cough severity, change in dyspnea severity, change in health-related quality of life, change in 6-min walk distance, and time to selected event-driven composite endpoints of disease progression.
In patients with IPF and abnormal acid GER, laparoscopic anti-reflux surgery is safe and well tolerated but did not significantly slow the rate of FVC decline. Further research is needed, particularly with a larger study in order to achieve sufficient statistical power, regarding the possible benefits of anti-reflux surgery in this population.
Raghu G, Pellegrini CA, Yow E, et al. Laparoscopic anti-reflux surgery for the treatment of idiopathic pulmonary fibrosis (WRAP-IPF): a multicentre, randomised, controlled phase 2 trial. The Lancet Respiratory Medicine. 2018;6(9):707-714. doi:10.1016/s2213-2600(18)30301-1.
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Resources AvailableStudy Datasets Only
- Data Dictionary (PDF - 584.6 KB)
- WRAP IPF CRF Annotation (PDF - 723.5 KB)
- WRAP IPF Protocol (PDF - 1.2 MB)
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