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

University of California San Francisco (UCSF)

Status: Completed

Conditions: Gastroesophageal Reflux; Idiopathic Pulmonary Fibrosis

Treatments: Procedure: Surgery

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01982968

Pro00049804

1UM1HL119089 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Control

No Intervention group

Description:

Subjects to receive standard anti-reflux treatment per clinical discretion

Surgery

Active Comparator group

Description:

Subjects will receive laparoscopic fundoplication surgery

Treatment:

Procedure: Surgery