Idiopathic Pulmonary FibrosisWRAP-IPFNCT01982968
Treatment of IPF With Laparoscopic Anti-Reflux Surgery
A study testing Surgery in people with Idiopathic Pulmonary Fibrosis and Gastroesophageal Reflux, run by University of California, San Francisco at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Gastroesophageal Reflux
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 5 sitesUnited States
- Study dates
- Dec 2013to Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Michigan
Ann Arbor, Michigan
University of Chicago
Chicago, Illinois
University of Wisconsin
Madison, Wisconsin
University of California
San Francisco, California
University of Washington
Seattle, Washington
About this study
Official title: 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.
Read the 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.
- Being tested
- Surgery
- Keywords
- Idiopathic pulmonary fibrosis, IPF, Gastroesophageal reflux, GER, GERD
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Also called Nissen fundoplication, Laparoscopic fundoplication, Laparoscopic anti-reflux surgery
Full fundoplication surgery for the treatment of abnormal GER
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Subjects to receive standard anti-reflux treatment per clinical discretion |
| Surgery | Active comparator | Subjects will receive laparoscopic fundoplication surgery Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Vital Capacity (FVC)
Change in FVC (in liters) between enrollment and 48 weeks.
Measured: Baseline and 48 weeks
Secondary outcomes (10)
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).
Measured: Baseline and 48 weeks
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.
Measured: 48 weeks
All-cause Mortality
Impact of anti-reflux surgery on all-cause mortality from enrollment to 48 weeks
Measured: 48 weeks
Non-elective Hospitalization
Impact on non-elective hospitalizations from baseline to 48 weeks.
Measured: Baseline and 48 weeks
Acute Exacerbations
Impact on acute exacerbations of IPF from baseline to week 48.
Measured: Baseline and 48 weeks
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.
Measured: Baseline and 48 weeks
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.
Measured: Baseline and 48 weeks
6-minute Walk Distance
Change in 6-minute walk distance from baseline to week 48
Measured: Baseline and 48 weeks
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.
Measured: Baseline and 48 weeks
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.
Measured: Baseline to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Harold R Collard, MD, Principal investigator, University of California, San FranciscoGanesh Raghu, MD, Principal investigator, University of WashingtonKevin J Anstrom, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982968
- Sponsor's protocol ID
- Pro00049804
- Other IDs
- 1UM1HL119089
- Acronym
- WRAP-IPF
- Status last verified
- Sep 2021
- First submitted
- 6 Nov 2013
- Last updated
- 25 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 30100404
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weighing Risks and Benefits of Laparoscopic Anti-Reflux Surgery in Patients With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT01982968
- Acronym / sponsor ID
- WRAP-IPF / Pro00049804
- Keywords
- Idiopathic pulmonary fibrosis, IPF, Gastroesophageal reflux, GER, GERD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Dec 2013
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 13 Nov 2013 (estimated)
- Results
- Posted 25 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Subjects to receive standard anti-reflux treatment per clinical discretion |
| Surgery | Active comparator | Procedure: SurgerySubjects will receive laparoscopic fundoplication surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryAlso: Nissen fundoplication, Laparoscopic fundoplication, Laparoscopic anti-reflux surgeryFull fundoplication surgery for the treatment of abnormal GER | Procedure or surgery | Surgery |
Primary outcome
Forced Vital Capacity (FVC)
Time frame: Baseline and 48 weeks
Change in FVC (in liters) between enrollment and 48 weeks.
10 secondary outcomes
Change in Score From Baseline for Acid and Non-acid Reflux Events at 48 Weeks
Time frame: Baseline and 48 weeks
Safety of Laparoscopic Anti-reflux Surgery
Time frame: 48 weeks
All-cause Mortality
Time frame: 48 weeks
Non-elective Hospitalization
Time frame: Baseline and 48 weeks
Acute Exacerbations
Time frame: Baseline and 48 weeks
University of California San Diego (UCSD) Shortness of Breath Questionnaire (SOQB) Score
Time frame: Baseline and 48 weeks
St. George's Respiratory Questionnaire (SGRQ) Score
Time frame: Baseline and 48 weeks
6-minute Walk Distance
Time frame: Baseline and 48 weeks
Cough Visual Analog Scale (VAS)
Time frame: Baseline and 48 weeks
High-Resolution CT (HRCT) Fibrosis Score.
Time frame: Baseline to 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30100404Raghu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harold R Collard, MD principal investigator
University of California, San Francisco
Ganesh Raghu, MD principal investigator
University of Washington
Kevin J Anstrom, PhD principal investigator
Duke University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery in people with Idiopathic Pulmonary Fibrosis and Gastroesophageal Reflux, run by University of California, San Francisco at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced Vital Capacity (FVC) (time frame: Baseline and 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01982968, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.