Hiatal Hernia and Pulmonary Involvement

Summary

Patients often present with a significant burden of fibrosis upon diagnosis as there is interest in identifying these individuals earlier in their disease course (i.e., "subclinical disease") where targeted treatments and modification of risk factors may curb their progression to fulminant fibrosing ILD. The investigators have investigated with computed tomography (CT) methods such as interstitial lung abnormalities (ILA) and high attenuation areas (HAAs) that may detect early radiological signs of interstitial lung inflammation and scarring and novel modifiable risk factors that contribute to its pathogenesis. Among adults without clinically-diagnosed pulmonary fibrosis, those with a hiatal hernia will have higher levels of pepsin in bronchoalveolar lavage fluid (BALF) compared with adults without a hiatal hernia. Secondarily, examinination on whether there are differences in other reflux contents from BALF including total bile, and peripheral biomarkers related to lung injury and fibrogenesis which include matrix metalloproteinase-7 (MMP-7), vascular cell adhesion molecule 1 (VCAM-1), and cancer antigen 125 (CA-125).

Conditions

• Hiatal Hernia
• Interstitial Lung Disease

Interventions

DIAGNOSTIC_TEST

Blood Collection

Prior to subject's surgical procedure, blood (about 3 tablespoons (44 mL)) will be collected through a needle in vein for research purposes. The UVA researchers will analyze the biomarkers that are expressed in subject's blood.

DIAGNOSTIC_TEST

Bronchoscopy

Following blood collection, the subject will undergo the bronchoscopy for research purposes. While in the operating room, a bronchoscope will be inserted through the breathing tube that is already been placed for the surgery. Subject's airways will be examined with the bronchoscope in both lungs. Ten tablespoons (150 mL) of saline solution will be injected into one of subject airways. The fluid will be re-collected by suctioning it back up with the bronchoscope. The fluid will be collected from the bronchscope.

Sponsors & Collaborators

• American College of Chest Physicians

  collaborator OTHER

• University of Virginia

  lead OTHER

Principal Investigators

• John Kim, MD · University of Virginia

• Roselove Asare, MA · UVA

• Yousef Althulth, MD · UVA

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-05

Primary Completion

2024-03-31

Completion

2025-12-31

Countries

• United States

Study Locations