N/A N=58 Randomized Treatment

Treatment of IPF With Laparoscopic Anti-Reflux Surgery

Idiopathic Pulmonary Fibrosis · Gastroesophageal Reflux

Bottom Line

View on ClinicalTrials.gov: NCT01982968 ↗

Enrolled (actual)

Serious AEs

22.4%

Results posted

Oct 2021

Primary outcome: Primary: Forced Vital Capacity (FVC) — -0.13; -0.05 liters

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Surgery (Procedure)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: University of California, San Francisco
Primary completion: Nov 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Forced Vital Capacity (FVC)	-0.13; -0.05	—
SECONDARY Change in Score From Baseline for Acid and Non-acid Reflux Events at 48 Weeks	-0.65; -1.04; -0.40; -0.39; -0.63; -1.13	—
SECONDARY Safety of Laparoscopic Anti-reflux Surgery	4; 1; 8; 5; 0; 9	—
SECONDARY All-cause Mortality	4; 1	—
SECONDARY Non-elective Hospitalization	8; 5	—
SECONDARY Acute Exacerbations	4; 1	—
SECONDARY University of California San Diego (UCSD) Shortness of Breath Questionnaire (SOQB) Score	0.69; 0.71	—
SECONDARY St. George's Respiratory Questionnaire (SGRQ) Score	-3.18; 1.04	—
SECONDARY 6-minute Walk Distance	9.13; 16.54	—
SECONDARY Cough Visual Analog Scale (VAS)	7.15; 4.74	—
SECONDARY High-Resolution CT (HRCT) Fibrosis Score.	—	—

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.

Eligibility Criteria

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 35
Known severe pulmonary hypertension (mean pressure > 35 mm Jg on RHC; RVSP > 50 mm Hg on ECHO)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01982968). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.