Hiatal Hernia and Pulmonary Involvement

NCT05716022 | Completed

• 1 other identifier: HSR220294
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hiatal Hernia; BALF; Interstitial lung Disease

Outcome Measures

Primary Outcomes (1)

• Bronchoalveolar lavage fluid pepsin levels

  Investigators examine whether bronchoalveolar lavage fluid levels of pepsin are significantly different by case (adults with hiatal hernia and/or gastroesophageal reflux undergoing surgical repair) and control status (adults without hiatal hernia). Pepsin levels will be measured by ELISA assay.

  Baseline

Secondary Outcomes (4)

• Serum matrix metalloproteinase-7

  Baseline

• Serum CA-125

  Baseline

• Serum vascular cell adhesion molecule-1

  Baseline

• RNA gene expression

  Baseline

Study Arms (2)

Hiatal Hernia Group

The subject has a history of acid reflux and/or hiatal hernia undergoing surgical repair by thoracic surgery at the University of Virginia.

Diagnostic Test: Blood Collection; Diagnostic Test: Bronchoscopy

Control Group

Patients undergoing bronchoscopy for clinical purposes at the University of Virginia endoscopy suite without a clinical diagnosis of hiatal hernia and/or pulmonary fibrosis.

Diagnostic Test: Blood Collection; Diagnostic Test: Bronchoscopy

Interventions

Blood Collection DIAGNOSTIC_TEST

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.

Control Group; Hiatal Hernia Group

Bronchoscopy DIAGNOSTIC_TEST

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.

Control Group; Hiatal Hernia Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Participants without a clinical diagnosis of pulmonary fibrosis will be recruited from UVA medical center based on the absence of traction bronchiectasis, honeycombing and/or reticular opacities on CT Scan. 2. Case group will be adults who have a clinical diagnosis of hiatal hernia already scheduled to under surgical repair 3. Control group will be adults without a CT diagnosis of hiatal hernia who have been scheduled to undergo Bronchoscopy for lung nodule evaluation.

You may qualify if:

• Able to provide written consent.
• Clinical diagnosis of hiatal hernia and/or gastroesophageal reflux undergoing pre-operative evaluation for surgical repair at the University of Virginia as part of clinical care.
• years and above.

You may not qualify if:

• Unable to provide written consent.
• Clinical diagnosis of pulmonary fibrosis.
• History of hiatal hernia (for control group only).
• Use of home supplemental oxygen therapy either at rest or exertion.
• Pregnant Women (will be confirmed as part of standard of care).

Sponsors & Collaborators

• American College of Chest Physicians: collaborator
• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (6)

• Kim JS, Kim J, Yin X, Hiura GT, Anderson MR, Hoffman EA, Raghu G, Noth I, Manichaikul A, Rich SS, Smith BM, Podolanczuk AJ, Garcia CK, Barr RG, Prince MR, Oelsner EC. Associations of hiatus hernia with CT-based interstitial lung changes: the MESA Lung Study. Eur Respir J. 2023 Jan 27;61(1):2103173. doi: 10.1183/13993003.03173-2021. Print 2023 Jan.

  PMID: 35777776 BACKGROUND

• Kim JS, Axelsson GT, Moll M, Anderson MR, Bernstein EJ, Putman RK, Hida T, Hatabu H, Hoffman EA, Raghu G, Kawut SM, Doyle MF, Tracy R, Launer LJ, Manichaikul A, Rich SS, Lederer DJ, Gudnason V, Hobbs BD, Cho MH, Hunninghake GM, Garcia CK, Gudmundsson G, Barr RG, Podolanczuk AJ. Associations of Monocyte Count and Other Immune Cell Types with Interstitial Lung Abnormalities. Am J Respir Crit Care Med. 2022 Apr 1;205(7):795-805. doi: 10.1164/rccm.202108-1967OC.

  PMID: 34929108 BACKGROUND

• Scott MKD, Quinn K, Li Q, Carroll R, Warsinske H, Vallania F, Chen S, Carns MA, Aren K, Sun J, Koloms K, Lee J, Baral J, Kropski J, Zhao H, Herzog E, Martinez FJ, Moore BB, Hinchcliff M, Denny J, Kaminski N, Herazo-Maya JD, Shah NH, Khatri P. Increased monocyte count as a cellular biomarker for poor outcomes in fibrotic diseases: a retrospective, multicentre cohort study. Lancet Respir Med. 2019 Jun;7(6):497-508. doi: 10.1016/S2213-2600(18)30508-3. Epub 2019 Mar 29.

  PMID: 30935881 BACKGROUND

• Wijsenbeek M, Cottin V. Spectrum of Fibrotic Lung Diseases. N Engl J Med. 2020 Sep 3;383(10):958-968. doi: 10.1056/NEJMra2005230. No abstract available.

  PMID: 32877584 BACKGROUND

• Lee JS, Song JW, Wolters PJ, Elicker BM, King TE Jr, Kim DS, Collard HR. Bronchoalveolar lavage pepsin in acute exacerbation of idiopathic pulmonary fibrosis. Eur Respir J. 2012 Feb;39(2):352-8. doi: 10.1183/09031936.00050911. Epub 2011 Dec 19.

  PMID: 22183478 BACKGROUND

• Noth I, Zangan SM, Soares RV, Forsythe A, Demchuk C, Takahashi SM, Patel SB, Strek ME, Krishnan JA, Patti MG, Macmahon H. Prevalence of hiatal hernia by blinded multidetector CT in patients with idiopathic pulmonary fibrosis. Eur Respir J. 2012 Feb;39(2):344-51. doi: 10.1183/09031936.00099910. Epub 2011 Jul 7.

  PMID: 21737563 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Bronchoalveolar lavage fluid samples Blood samples

MeSH Terms

Conditions

Hernia, Hiatal; Lung Diseases, Interstitial

Interventions

Blood Specimen Collection; Bronchoscopy

Condition Hierarchy (Ancestors)

Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Diagnostic Techniques, Respiratory System; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• John Kim, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

• Roselove Asare, MA

  UVA

  STUDY DIRECTOR

• Yousef Althulth, MD

  UVA

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: February 8, 2023
• Study Start: January 5, 2023
• Primary Completion: March 31, 2024
• Study Completion: December 31, 2025
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Will become available 24 months after completion of study upon request to principal investigator.

Locations

US (1)