ESPRESSO (Epidemiology Strengthened by histoPathology Reports in Sweden) (ESPRESSO)

The ESPRESSO study is a collection of data from all computerised gastrointestinal histopathology reports in Sweden. This allows us to study risk factors for gastrointestinal disease, as well as the prognosis of gastrointestinal disease.

A review of the study has been published here:

https://pubmed.ncbi.nlm.nih.gov/30679926/

Study Overview

• Status: Active, not recruiting
• Conditions: Gastrointestinal Diseases
• Intervention / Treatment: Other: ESPRESSO [The study has no intervention]

Detailed Description

The ESPRESSO study constitutes a novel approach to examine the etiology and prognosis of gastrointestinal disease in which histopathology plays a prominent role. Between 2015 and 2017, all pathology departments (n=28) in Sweden were contacted and asked to procure histopathology record data from the gastrointestinal tract (pharynx to anus), liver, gallbladder, and pancreas. For each individual, local histopathology IT personnel retrieved data on personal identity number, date of histopathology, topography (where the biopsy is taken), morphology (biopsy appearance), and where available free text. In total, between 1965 and 2017, histopathology record data were available in 2.1 million unique individuals, but the number of data entries was 6.1 million because more than one biopsy was performed in many of the study participants. Index individuals with histopathology data were matched with up to five controls from the general population. The investigators also identified all first-degree relatives (parents, children, full siblings), and the index individual's first spouse. The total study population consisted of 13.0 million individuals. Data from all the study participants have been linked to Swedish National Healthcare Registers allowing research not only on such aspects as fetal and perinatal conditions and the risk of future gastrointestinal disease but also on the risk of comorbidity and complications (including cancer and death). Furthermore, the ESPRESSO database allows researchers and practitioners to identify diagnoses and disease phenotypes not currently indexed in national registers (including disease precursors). The ESPRESSO database increases the sensitivity and specificity of already-recorded diseases in the national health registers. This paper is an overview of the ESPRESSO database.

• Study Type: Observational
• Enrollment (Actual): 13000000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Males 45.8% Median age at biopsy: 58 years

Description

Inclusion Criteria:

• Any person with a computerised histopathology record from the gastrointestinal tract including the liver, gallbladder and the pancreas.
• Matched controls to any person with the above histopathology record.
• Spouses and first-degree relatives to any of the above.

Exclusion Criteria:

-None

(this is a registry-based study)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incident Mortality [especially rates]	Record of death in the Swedish Cause of Death Register. Please note: Different sub-projects will have different primary outcomes.	Currently up until 2022

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incident Cancer	ICD (international classification of diseases) code in the Swedish nationwide cancer register.	Currently up until 2022
Incident Cardiovascular disease	ICD (international classification of diseases) code in the Swedish nationwide Patient Register, and where appropriate also the Cause of Death Register	Currently up until 2022
Incident Neurological disease	ICD (international classification of diseases) code in the Swedish nationwide Patient Register, and where appropriate also the Cause of Death Register	Currently up until 2022
Incident Autoimmune diseases	ICD (international classification of diseases) code in the Swedish nationwide Patient Register, and where appropriate also the Cause of Death Register	Currently up until 2022

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Please note that the recorded outcomes above are examples. Other outcomes may also be studied.	ICD codes as above	Currently up until 2022

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Jonas F Ludvigsson, MD, PhD, Karolinska Institutet

Publications and helpful links

General Publications

• Ludvigsson JF, Lashkariani M. Cohort profile: ESPRESSO (Epidemiology Strengthened by histoPathology Reports in Sweden). Clin Epidemiol. 2019 Jan 14;11:101-114. doi: 10.2147/CLEP.S191914. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 1965
• Primary Completion (Estimated): May 17, 2043
• Study Completion (Estimated): May 17, 2043

Study Registration Dates

• First Submitted: March 27, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: pancreas; endoscopy; liver; colon; cohort; gut; inflammatory bowel disease; colitis; gallbladder; esophagus; pathology; celiac; population-based
• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: 2014/1287-31/4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to make individual participant data (IPD) available to other researchers. (such sharing is not consistent with the rules from the Swedish government agency: Statistics Sweden).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No