Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000263998
Ethics application status
Approved
Date submitted
14/02/2020
Date registered
27/02/2020
Date last updated
27/02/2020
Date data sharing statement initially provided
27/02/2020
Date results information initially provided
27/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Distinguishing Gastroesophageal Reflux Disease and Eosinophilic Esophagitis in Adults: the Role Esopahegal Mucosal Immunoglobulin IG4
Scientific title
Distinguishing Gastroesophageal Reflux Disease and Eosinophilic Esophagitis in Adults: the Role Esopahegal Mucosal Immunoglobulin IG4
Secondary ID [1] 300557 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eosinophilic oesophagitis 316278 0
Gastroesophageal reflux disease 316279 0
Condition category
Condition code
Oral and Gastrointestinal 314556 314556 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 314642 314642 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 316855 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322876 0
Distinguishing EoE using IgG4 staining. All biopsies 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.
Timepoint [1] 322876 0
1 week post staining by pathologist
Primary outcome [2] 323059 0
Distinguishing GERD using IgG4 staining. All biopsies 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.
Timepoint [2] 323059 0
1 week post staining by pathologist
Secondary outcome [1] 380115 0
N/A
Timepoint [1] 380115 0
N/A

Eligibility
Key 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
11/09/2017
Date of last participant enrolment
Anticipated
Actual
31/12/2019
Date of last data collection
Anticipated
Actual
31/12/2019
Sample size
Target
30
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 15885 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 29342 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 304967 0
Hospital
Name [1] 304967 0
Royal Adelaide Hospital
Country [1] 304967 0
Australia
Primary sponsor type
Other Collaborative groups
Name
GI and Pancreatic Researchs Group
Address
5E291, RAH, Port Road, Adelaide, 5000, SA, Australia
Country
Australia
Secondary sponsor category [1] 305326 0
None
Name [1] 305326 0
Address [1] 305326 0
Country [1] 305326 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305378 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 305378 0
Royal Adelaide Hospital
Port Road,
Adelaide SA 5000
Ethics committee country [1] 305378 0
Australia
Date submitted for ethics approval [1] 305378 0
Approval date [1] 305378 0
10/09/2017
Ethics approval number [1] 305378 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100174 0
Dr Stephanie Wong
Address 100174 0
5E291, Royal Adelaide Hospital, Port Road, Adelaide, 5000, SA
Country 100174 0
Australia
Phone 100174 0
+61 8 70742189
Fax 100174 0
Email 100174 0
romina.safaeian@sa.gov.au
Contact person for public queries
Name 100175 0
Romina Safaeian
Address 100175 0
5E291, RAH, Port Road, Adelaide, 5000, SA
Country 100175 0
Australia
Phone 100175 0
+61 8 70742189
Fax 100175 0
Email 100175 0
romina.safaeian@sa.gov.au
Contact person for scientific queries
Name 100176 0
Romina Safaeian
Address 100176 0
5E291, RAH, Port Road, Adelaide, 5000, SA
Country 100176 0
Australia
Phone 100176 0
+61 8 70742189
Fax 100176 0
Email 100176 0
romina.safaeian@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.