Acute pancreatitis Digestive System
Conditions
Interventions
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,
Sponsors
University of Pécs, Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Does not meet the inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Hungary
Outcome results
None listed