Observational longitudinal multicentre investigation of acute pancreatitis (GOULASH PLUS): follow-up of the GOULASH study, protocol.

Abstract

BACKGROUND:

Acute pancreatitis (AP) is an inflammatory condition that can lead to late consequences. Recurrent AP (RAP) develops in 20% of patients and chronic pancreatitis (CP) occurs in 7%-12.8%. However, we do not have sufficient information to establish an evidence-based statement to define early CP, or how to prevent its development.

AIM:

The aim of this study was to understand the influencing factors and to determine which parameters should be measured or used as a biomarker to detect the early phase of CP.

METHODS/DESIGN:

This is an observational prospective follow-up study of the GOULASH-trial (ISRTCN 63827758) in which (1) all severity of pancreatitis are included; (2) patients receive only therapeutic modalities which are accepted by the evidence based medicine (EBM) guideline; (3) whole blood, serum and plasma samples are stored in our biobank; and (4) large amount of variables are collected and kept in our electronic database including anamnestic data, physical examination, laboratory parameters, imaging, therapy and complications. Therefore, this fully characterised patient cohort are well suitable for this longitudinal follow-up study. Patients' selection: patients enrolled in the GOULASH study will be offered to join to the longitudinal study. The follow-up will be at 1, 2, 3, 4, 5 and 6 years after the episode of AP. Anamnestic data will be collected by questionnaires: (1) diet history questionnaire, (2) 36-Item Short-Form Health Survey, (3) physical activity questionnaire and (4) stress questionnaire. Genetic tests will be performed for the genes associated with CP. The exocrine and endocrine pancreatic, liver and kidney functions will be determined by laboratory tests, stool sample analyses and imaging. Cost-effectiveness will be analysed to examine the relationship between events of interest and health-related quality of life or to explore subgroup differences.

CONCLUSION:

This study will provide information about the risk and influencing factors leading to CP and identify the most useful measurable parameters.

TRIAL REGISTRATION NUMBER:

ISRCTN63396106.

• Authors: Alexandra Mikó, Bálint Erőss, Patrícia Sarlós, Péter Hegyi Jr, Katalin Márta, Dániel Pécsi, Áron Vincze, Beáta Bódis, Orsolya Nemes, Nándor Faluhelyi, Orsolya Farkas, Róbert Papp, Dezső Kelemen, Andrea Szentesi, Eszter Hegyi, Mária Papp, László Czakó, Ferenc Izbéki, László Gajdán, János Novák, Miklós Sahin-Tóth, Markus M Lerch, John Neoptolemos, Ole H Petersen, Péter Hegyi
• Journal: BMJ open (BMJ Open) Vol. 9 Issue 8 Pg. e025500 (09 03 2019) ISSN: 2044-6055 [Electronic] England
• PMID: 31481363 (Publication Type: Journal Article, Multicenter Study, Observational Study, Research Support, Non-U.S. Gov't)
• Copyright: © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Chemical References

• Biomarkers

Topics

• Biomarkers (blood)
• Early Diagnosis
• Follow-Up Studies
• Humans
• Longitudinal Studies
• Pancreatitis (blood, diagnosis, etiology)
• Prospective Studies
• Risk Factors
• Surveys and Questionnaires