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.

Keywords: acute pancreatitis; chronic pancreatitis; follow-up; pancreatic disease; risk factor.

Conflict of interest statement

Competing interests: None declared.

© 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.

Figures

Figure 1

Flow chart of participants in the GOULASH PLUS study. CP, chronic pancreatitis; EUS, endoscopic ultrasonography; OGTT, oral glucose tolerance test; US, ultrasonography.

Figure 2

Shows the schedule of enrolment and assessments of participants according to the SPIRIT 2013 guideline. *A total of 957 patients participated in the GOULASH study. **The Administrator will call the patient’s attention to follow-up visits by telephone. ***Based on the preliminary data concerning the compliance with the 1-month follow-up, we estimate dropouts and participants who do not sign the consent form. ****Oral glucose tolerance test (OGTT) will be performed if diabetes mellitus is unknown and the fasting plasma glucose is level is ≤7 mmol/L. *****Based on morphological changes, the radiologist may recommend CT, endoscopic ultrasonography or MRI examination. ******In the University of Pécs, samples in the biobank will be kept to measure any kind of possible biomarkers which could be a candidate in the diagnosis of early phase of chronic pancreatitis. *******The questionnaires will be completed by the clinical research administrators. ******** It will be performed in the University of Pécs and Szeged.