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Distinguishing Gastroesophageal Reflux Disease and Eosinophilic Esophagitis in Adults: the Role Esopahegal Mucosal Immunoglobulin IG4

Distinguishing Gastroesophageal Reflux Disease and Eosinophilic Esophagitis in Adults: the Role Esopahegal Mucosal Immunoglobulin IG4

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12620000263998
Enrollment
60
Registered
2020-02-27
Start date
2017-09-11
Completion date
2019-12-31
Last updated
2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Background: Eosinophilic esophagitis (EoE) and gastroesophageal reflux disease (GERD) can be difficult to distinguish as many of their clinical and histological features overlap. Preliminary data suggests a potential association between EoE and immunoglobulin G4 (IgG4), but not GERD. Aim: To examine the role of esophageal mucosal IgG4 staining in differentiating EoE from GERD. Methods: Esophageal biopsy specimens from patients with proven EoE and GERD were evaluated and immunohistochemical staining for IgG4 was performed by an experienced gastrointestinal pathologist blinded from the clinical and endoscopic data. The results on IgG4 staining was then correlated with clinical, endoscopic and histological features.

Interventions

IgG4 staining was performed prospectively on retrospective specimens. Thus, the ethics committee approved the study to proceed without requiring patient consent. Medical records were accessed as approved by the ethics committee. This was a single cross-sectional assessment. All biopsies with either EoE or GORD will undergo immunohistochemical staining for IgG4 using DAKO Autostainer Plus Staining System. A single pathologist who specializes in gastrointestinal pathology will perform all immunohi

IgG4 staining was performed prospectively on retrospective specimens. Thus, the ethics committee approved the study to proceed without requiring patient consent. Medical records were accessed as approved by the ethics committee. This was a single cross-sectional assessment. All biopsies with either EoE or GORD will undergo immunohistochemical staining for IgG4 using DAKO Autostainer Plus Staining System. A single pathologist who specializes in gastrointestinal pathology will perform all immunohistochemical staining and interpretation of the slides in a blinded manner.

Sponsors

GI and Pancreatic Researchs Group
Lead SponsorOther Collaborative groups

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

GERD: -18-80 years of age -typical symptoms of GERD responsive to PPI therapy -evidence of oesophagitis on endoscopy with supportive oesophageal biopsy specimens --eosinophil count <10/hpf EoE: -18-80 years of age, symptoms of oesophageal dysfunction with 'greater than or equal to' 15 eosinophils/hpf -exclusion of other causes of eosinophilia

Exclusion criteria

Exclusion criteria were history of severe respiratory, cardiovascular, hepatic, haematological and/or renal disease, chronic alcohol abuse, medications that may influence gastrointestinal function and previous gastrointestinal surgery.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026