Treatment of IPF With Laparoscopic Anti-Reflux Surgery

NCT01982968 | Completed Results DMC

• 2 other identifiers: Pro000498041UM1HL119089
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Idiopathic Pulmonary Fibrosis; Gastroesophageal Reflux

Keywords

Idiopathic pulmonary fibrosis; IPF; Gastroesophageal reflux; GER; GERD

Outcome Measures

Primary Outcomes (1)

• Forced Vital Capacity (FVC)

  Change in FVC (in liters) between enrollment and 48 weeks.

  Baseline and 48 weeks

Secondary Outcomes (10)

• Change in Score From Baseline for Acid and Non-acid Reflux Events at 48 Weeks

  Baseline and 48 weeks

• Safety of Laparoscopic Anti-reflux Surgery

  48 weeks

• All-cause Mortality

  48 weeks

• Non-elective Hospitalization

  Baseline and 48 weeks

• Acute Exacerbations

  Baseline and 48 weeks

Study Arms (2)

Control

NO INTERVENTION

Subjects to receive standard anti-reflux treatment per clinical discretion

Surgery

ACTIVE COMPARATOR

Subjects will receive laparoscopic fundoplication surgery

Procedure: Surgery

Interventions

Surgery PROCEDURE

Full fundoplication surgery for the treatment of abnormal GER

Also known as: Nissen fundoplication, Laparoscopic fundoplication, Laparoscopic anti-reflux surgery

Surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (5)

University of California

San Francisco, California, United States

Location

University of Chicago

Chicago, Illinois, United States

Location

University of Michigan

Ann Arbor, Michigan, United States

Location

University of Washington

Seattle, Washington, United States

Location

University of Wisconsin

Madison, Wisconsin, United States

Location

Related Publications (1)

• 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.

  PMID: 30100404 RESULT

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Gastroesophageal Reflux

Interventions

Surgical Procedures, Operative; Fundoplication

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures

Results Point of Contact

• Title: Harold Collard, MD
• Organization: University of California, San Francisco

Harold.Collard@ucsf.edu

415 4761000

Study Officials

• Harold R Collard, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Ganesh Raghu, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Kevin J Anstrom, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2013
• First Posted: November 13, 2013
• Study Start: December 1, 2013
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: October 25, 2021
• Results First Posted: October 25, 2021

Record last verified: 2021-09

Locations

US (5)