What are the first measurable signs of the early phase of chronic pancreatitis?
| ISRCTN | ISRCTN63396106 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63396106 |
- Submission date
- 03/12/2018
- Registration date
- 05/02/2019
- Last edited
- 11/01/2024
- Recruitment status
- Suspended
- Overall study status
- Ongoing
- Condition category
- Digestive System
Plain English summary of protocol
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, 5 and 6 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?
December 2017 to February 2030
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
Contact information
Scientific
Szigeti str 12
Pécs
H-7624
Hungary
 ORCID ID |
0000-0003-0399-7259 |
|---|---|
| Phone | +36 72 536250 |
| hegyi.peter@pte.hu |
Study information
| Study design | Observational prospective follow-up study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Observational longitudinal multicentre investigation of acute pancreatitis. (GOULASH PLUS): Follow-up of the GOULASH study |
| Study acronym | GOULASH PLUS |
| Study objectives | Current hypothesis as of 08/04/2019: Acute pancreatitis (AP) is an inflammatory condition, which can lead to late consequences. In 20% of patients recurrent AP (RAP) develops and in 7-12% 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. Previous 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(s) |
Approved 08/02/2018, Secretary of Medical Research Council Scientific and Research Ethics Committee (P.O.B 314, Budapest, H-1903, Hungary; (+36 1) 795 1192; attilane.gombos@bm.gov.hu), ref: 5753-2/2018/EKU |
| Health condition(s) or problem(s) studied | Acute pancreatitis |
| Intervention | Current intervention as of 08/04/2019: 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, 5 and 6 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, 5 and 6 years, and imaging (abdominal ultrasound in years 1, 3 and 5 and endoscopic ultrasound in years 2, 4 and 6). 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, 5 and 6 years after the episode of acute pancreatitis. Previous 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 |
| Primary outcome measure | Current primary outcome measures as of 08/04/2019: 1. Incidence of CP assessed once yearly for 6 years using abdominal ultrasound in years 1, 3 and 5 and endoscopic ultrasound in years 2, 4 and 6 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 6 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 6 years 4. Incidence of endocrine pancreatic insufficiency (based on oral glucose tolerance test [OGTT] and fasting plasma glucose [FPG] test) once yearly for 6 years if the patient has not already been diagnosed with diabetes mellitus and the fasting plasma glucose level is ≤7 mmol/l Previous primary outcome measures: 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 | Current secondary outcome measures as of 08/04/2019: 1. Need for radiological/surgical interventions assessed by reviewing patient medical records in every follow-up visit during the 6-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 6 years 3. Quality of life assessed using RAND 36-Item Health Survey Version 1.0 SF-36 once a year for 6 years 4. Stress assessed using the 10-item Perceived Stress Scale once a year for 6 years 5. Physical activity assessed using International Physical Activity Questionnaire (IPAQ; long, usual week version) once a year for 6 years 6. Pain assessed by RAND 36-Item Health Survey Version 1.0 SF-36 once a year for 6 years 7. Development of pancreas tumor and cystic lesions assessed by reviewing patient medical records once a year for 6 years 8. Laboratory parameters to assess organ function – inflammatory cytokines, pancreatic peptides etc once a year for 6 years Previous 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 study start date | 01/12/2017 |
| Completion date | 28/02/2030 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 577 |
| Key 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 |
| Key exclusion criteria | Does not meet the inclusion criteria |
| Date of first enrolment | 31/01/2019 |
| Date of final enrolment | 28/01/2025 |
Locations
Countries of recruitment
- Hungary
Study participating centres
Pécs
H-7624
Hungary
Debrecen
H-4012
Hungary
Székesfehérvár
H-8000
Hungary
Budapest
1083
Hungary
Sponsor information
Government
Szigeti str 12
Pécs
H-7624
Hungary
| Phone | +36 72 536250 |
|---|---|
| hegyi.peter@pte.hu | |
| Website | www.aok.pte.hu |
"ROR" |
https://ror.org/037b5pv06 |
Funders
Funder type
University/education
No information available
No information available
No information available
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We plan to publish the trial results in a Q1 high-quality international journal. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 03/09/2019 | 21/08/2020 | Yes | No |
Editorial Notes
11/01/2024: The following changes were made to the trial record:
1. The overall end date was changed from 28/02/2025 to 28/02/2030.
2. The study participating centres University of Szeged 1st Department of Medicine, Pándy Kálmán Hospital of Békés County were removed and Institute of Pancreatic Diseases, Semmelweis University was added.
21/08/2020: Publication reference added.
04/05/2020: Due to current public health guidance, recruitment for this study has been paused.
04/04/2019: The following changes have been made:
1. The study hypothesis has been changed.
2. The intervention has been changed.
3. The primary outcome measures have been changed.
4. The secondary outcome measures have been changed.
5. The target number of participants has been changed from 766 to 577.
6. The recruitment end date has been changed from 31/01/2025 to 28/01/2025.
7. The plain English summary has been updated to reflect the change in follow-up time from 5 to 6 years.
03/12/2018: This a follow-up study of the GOULASH study (ISRCTN63827758).
