Treatment of IPF With Laparoscopic Anti-Reflux Surgery (WRAP-IPF)

September 27, 2021 updated by: University of California, San Francisco

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States
        • University of California
    • Illinois
      • Chicago, Illinois, United States
        • University of Chicago
    • Michigan
      • Ann Arbor, Michigan, United States
        • University of Michigan
    • Washington
      • Seattle, Washington, United States
        • University of Washington
    • Wisconsin
      • Madison, Wisconsin, United States
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
Subjects to receive standard anti-reflux treatment per clinical discretion
ACTIVE_COMPARATOR: Surgery
Subjects will receive laparoscopic fundoplication surgery
Procedure: Surgery
Full fundoplication surgery for the treatment of abnormal GER
Other Names:
  • Nissen fundoplication
  • Laparoscopic fundoplication
  • Laparoscopic anti-reflux surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced Vital Capacity (FVC)
Time Frame: Baseline and 48 weeks
Change in FVC (in liters) between enrollment and 48 weeks.
Baseline and 48 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Kevin J Anstrom, PhD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (ACTUAL)

November 1, 2017

Study Completion (ACTUAL)

November 1, 2017

Study Registration Dates

First Submitted

November 6, 2013

First Submitted That Met QC Criteria

November 6, 2013

First Posted (ESTIMATE)

November 13, 2013

Study Record Updates

Last Update Posted (ACTUAL)

October 25, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00049804
  • 1UM1HL119089 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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