Clinical trial NCT02305914: Follow-up Study of Complications of Acute Pancreatitis
Official title: A Large Sample Follow-up Study of Long-term Complications of Acute Pancreatitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatitis
Pancreatic Neoplasms
Metabolic Diseases
Hypertension, Portal
Respiratory Failure
Quality of Life
Keywords: acute pancreatitis
chronic pancreatitis
pancreatic cancer
pancreatic disease-associated portal hypertension
autoimmune pancreatitis
PaO2/FiO2<200
diabetes mellitus
blood lipid
local complications
quality of life
Lead sponsor: The First Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2014-12-03
Enrollment: 1300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical diagnosis of acute pancreatitis from the First Affiliated Hospital of Nanchang University from 2005 and 2014,with a follow-up interval of at least 1 year.

Brief summary: This is a follow-up study focusing on long-term complications of acute pancreatitis. The primary purposes include: 1. To assess the incidence of type 2 diabetes mellitus（2-DM）,impaired glucose tolerance, metabolic abnormalities of blood lipids after acute pancreatitis. 2. To observe the possible long-term clinical outcomes after acute pancreatitis attack, which may include: chronic pancreatitis, pancreatic cancer, pancreatogenic portal hypertension, autoimmune pancreatitis et al. 3. To evaluate the long-term influence of acute lung injury(PaO2/FiO2\<200,FiO2 means fraction of inspiration O2) in AP patients during ICU stay on life qualities of the patients; 4. To observe the prognosis of the local complications of acute pancreatitis(AP) patients; it might be helpful to find the most effective and targeted interventions aiming at different phases after AP attack.

Detailed description: Currently，follow-up study is limited on glucose intolerance and life quality assessment. However, it has been shown that AP is associated to some extent with other diseases such as chronic pancreatitis, pancreatic cancer, pancreatogenic portal hypertension and autoimmune pancreatitis; In addition, for patients who have severe lung injury following AP, especially with PaO2/FiO2\<200 during ICU stay, the long term prognosis remains unclear. Thus, a large sample follow-up study is essential for elucidating the possible long-term complications.

Prior to follow up study, the investigators performed baseline analysis of AP patient data from the database of the First Affiliated Hospital of Nanchang University. It is estimated that 1300 patients will be interviewed over telephone and 600 patients in the outpatient department. The content of the follow-up includes: questionnaire (the MOS\[medical outcome study\] item short from health survey, SF\[short form\]-36) ; lab testing(complete blood count, blood chemistry such as liver and kidney function, C-reaction protein(CRP), AMY, fasting blood-glucose，1 and 2 hour postprandial blood glucose,C-peptide, blood lipids, FE-1) and CT scan. For patients who have severe lung injuries during ICU stay, pulmonary function test, Blood gas analysis and chest CT will be performed. After screening, the patients with chronic pancreatitis(CP), pancreatic cancer(PC), post Pancreatogenic portal hypertension（PPH） or autoimmune pancreatitis(AIP）will be hospitalized for further therapy.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of acute pancreatitis from our hospital
* Must be signed the informed consent

Exclusion Criteria:

* Failed to complete the questionnaire survey and the follow-up examination

Primary outcomes:
measure: change in glucose
timeFrame: An expected duration which estimated to be average of 4.2 years
measure: Change in C-Peptide
timeFrame: An expected duration which estimated to be average of 4.2 years
measure: Change in blood liquid
timeFrame: An expected duration which estimated to be average of 4.2 years
measure: Change in the Levels of fecal elastase-1
timeFrame: An expected duration which estimated to be average of 4.2 years
Secondary outcomes:
measure: Abdomen CT
timeFrame: An expected duration which estimated to be average of 4.2 years
measure: the MOS item short from health survey, SF-36
timeFrame: An expected duration which estimated to be average of 4.2 years
measure: outpatient clinic and phone questionnaire
timeFrame: An expected duration which estimated to be average of 4.2 years
Other outcomes:
Locations:
city: Nanchang
country: China
facility: the First Affiliated Hospital of Nanchang University
state: Jiangxi
Study officials:
affiliation: The First Affiliated Hospital of Nanchang University
name: Nonghua Lv, MD
role: STUDY_CHAIR
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