Condition category
Digestive System
Date applied
03/12/2018
Date assigned
05/02/2019
Last edited
05/02/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Chronic pancreatitis (CP) is a severe disease which might be prevented by changing diet, smoking, alcohol consumption habits, and physical activity, however it is not known what to suggest to patients to decrease the risk of disease development. This study aims to find the first signs of the disease, when the progression could be slowed down and the prevention of recurrent acute pancreatitis (RAP) and CP could be started at the optimal time. The aim is to find the risk factors which worsen the progress of acute pancreatitis (AP) to RAP and CP. With this information, we could save lives, enhance the quality of life of patients, reduce the costs of health care, and new therapeutic targets could also be identified.

Who can participate?
Patients with acute pancreatitis enrolled in the GOULASH study

What does the study involve?
Participants are followed up 1, 2, 3, 4 and 5 years after the episode of AP. Data about eating habits, stress and physical activity will be collected by questionnaires. Laboratory tests are carried out on blood samples and genetic tests are performed for the genes already known to be associated with CP. The researchers also test for diabetes and ineffective pancreas enzyme production. Pancreas imaging is also performed every year. Blood and faeces samples are stored in the biobank for later laboratory tests.

What are the possible benefits and risks of participating?
Participants might benefit from regular and thorough monitoring for the earliest signs of CP development. The only potential disadvantage in participating is that filling in the questionnaires is time-consuming and must be filled in with the help of a trained healthcare worker, which means it can’t be done prior to the follow-up visit.

Where is the study run from?
It is a multicentre trial, open for centres who take part in the GOULASH study, designed with help of the Centre for Translational Medicine at the University of Pécs, the leading centre of the study.

When is the study starting and how long is it expected to run for?
The study will start in January 2019 and run until 28th February 2025. A pilot study was conducted previously with 68 included patients.

Who is funding the study?
The University of Pécs using grants from the Hungarian government

Who is the main contact?
Dr Alexandra Mikó
miko.alexandra@pte.hu

Trial website

www.tm-centre.org

Contact information

Type

Scientific

Primary contact

Prof Péter Hegyi

ORCID ID

http://orcid.org/0000-0003-0399-7259

Contact details

Szigeti str 12
Pécs
H-7624
Hungary
+36 72 536250
hegyi.peter@pte.hu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

GOULASH PLUS

Study hypothesis

Acute pancreatitis (AP) is an inflammatory condition, which can lead to late consequences. In 20% of patients recurrent AP (RAP) develops and in 5% chronic pancreatitis (CP) occurs. Chronic pancreatitis (CP) usually diagnosed at the end-stage, when fibrosis and exocrine and/or endocrine insufficiency are present. There is no gold standard therapy yet. In order to detect the first signs, risk factors and measurable parameters of early CP we plan to follow the late complications of acute and recurrent pancreatitis. By the early recognition of CP or the risks of CP the outcome of the disease can be improved, life expectancy can be increased, therefore the quality of life can improve and costs can be decreased.

The aim of the GOULASH-PLUS study is to understand the influencing factors and to determine which parameters should be measured to detect the early phase of CP.

Ethics approval

Secretary of Medical Research Council Scientific and Research Ethics Committee, 08/02/2018, ref: 5753-2/2018/EKU

Study design

Observational prospective follow-up study

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Acute pancreatitis

Intervention

This trial is designed as an observational study, no intervention is performed.
Anamnestic data will be collected by the following questionnaires at 1, 2, 3, 4 and 5 years after the episode of acute pancreatitis:
i) Diet History Questionnaire
ii) SF-36
iii) physical activity questionnaire
iv) stress questionnaire
Genetic tests will be performed for the genes already known to be associated with chronic pancreatitis.
The exocrine and endocrine pancreatic, liver and kidney functions will be determined by several laboratory tests and stool sample analyses at 1, 2, 3, 4 and 5 years, and imaging (abdominal ultrasound in years 1, 3 and 4 and endoscopic ultrasound in years 2 and 5).
Cost-effectiveness will be analyzed to examine the relationship between events of interest and health-related quality of life or to explore differences of the subgroup .
Participants will be followed up at 1, 2, 3, 4 and 5 years after the episode of acute pancreatitis.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Incidence of CP assessed once yearly for 5 years using abdominal ultrasound in years 1, 3 and 4 and endoscopic ultrasound in years 2 and 5
2. Incidence of recurrent AP based on the IAP/APA guideline’s 2 out of 3 rule. Patients will be followed up at least once a year for 5 years and will be asked to bring all medical records for review and discussion.
3. Incidence of exocrine pancreatic insufficiency assessed using the presence of steatorrhoea and the fecal elastase test assesed once yearly for 5 years
4. Incidence of endocrine pancreatic insufficiency (based on oral glucose tolerance test [OGTT] and fasting plasma glucose [FPG] test) once yearly for 5 years if the patient has not already been diagnosed with diabetes mellitus and the fasting plasma glucose level is ≤7 mmol/l

Secondary outcome measures

1. Need for radiological/surgical interventions assessed by reviewing patient medical records in every follow-up visit during the 5-year follow-up period.
2. Dietary intake assessed using Diet History Questionnaire (Version 2.0. National Institutes of Health) on follow-up visits once a year for 5 years
3. Quality of life assessed using RAND 36-Item Health Survey Version 1.0 SF-36 once a year for 5 years
4. Stress assessed using the 10-item Perceived Stress Scale once a year for 5 years
5. Physical activity assessed using International Physical Activity Questionnaire (IPAQ; long, usual week version) once a year for 5 years
6. Pain assessed by RAND 36-Item Health Survey Version 1.0 SF-36 once a year for 5 years
7. Development of pancreas tumor and cystic lesions assessed by reviewing patient medical records once a year for 5 years
8. Laboratory parameters to assess organ function – inflammatory cytokines, pancreatic peptides etc once a year for 5 years

Overall trial start date

01/12/2017

Overall trial end date

28/02/2025

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged over 18 years
2. Diagnosed with AP on the basis of the '2 out of 3' rule of the IAP/APA guideline: (a) upper abdominal pain; (b) serum amylase or lipase >3x upper limit of normal range; (c) characteristic findings on pancreatic imaging; however those patients without abdominal pain will be excluded because the onset of acute pancreatitis cannot be assessed
3. Participated in GOULASH study and signed the informed consent form

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

766

Participant exclusion criteria

Does not meet the inclusion criteria

Recruitment start date

31/01/2019

Recruitment end date

31/01/2025

Locations

Countries of recruitment

Hungary

Trial participating centre

University of Pécs Medical School Institute for Translational Medicine
Szigeti str 12
Pécs
H-7624
Hungary

Trial participating centre

University of Debrecen 2nd Department of Internal Medicine, Division of Gastroenterology
98 Nagyerdei boulevard
Debrecen
H-4012
Hungary

Trial participating centre

University of Szeged 1st Department of Medicine
8-10 Korányi Alley
Szeged
H-6720
Hungary

Trial participating centre

Pándy Kálmán Hospital of Békés County
1 Semmelweis Street
Gyula
H-5700
Hungary

Trial participating centre

Centre of Székesfehérvár Szent György University Teaching Hospital of Fejér County
3 Seregélyesi Street
Székesfehérvár
H-8000
Hungary

Sponsor information

Organisation

University of Pécs, Medical School

Sponsor details

Szigeti str 12
Pécs
H-7624
Hungary
+36 72 536250
hegyi.peter@pte.hu

Sponsor type

Government

Website

www.aok.pte.hu

Funders

Funder type

University/education

Funder name

University of Pécs Medical School

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Momentum Grant of the Hungarian Academy of Sciences (LP2014-10/2014)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Highly Cited Publication Grant (KH 125678) of the National Research Development

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Innovation Office (GINOP 2.3.2-15-2016-00048 Stay Alive)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Innovation Office (EFOP 3.6.2-16-2017-00006 Live Longer)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Translational Medicine Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We plan to publish the trial results in a Q1 high-quality international journal.

IPD sharing statement:
All parameters of the dataset will be available upon request from the principal investigator (Prof Péter Hegyi, University of Pécs Medical School Institute for Translational Medicine) after the results have been published.

Intention to publish date

31/12/2025

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

03/12/2018: This a follow-up study of the GOULASH study (ISRCTN63827758).