Follow-up Study of Complications of Acute Pancreatitis

• Conditions: Pancreatitis; Quality of Life; Hypertension, Portal; Respiratory Failure; Pancreatic Neoplasms; Metabolic Diseases

• Registration Number: NCT02305914
• Lead Sponsor: The First Affiliated Hospital of Nanchang University

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.

Study Timeline

• Status Verified: 2014-11
• Study Start: 2014-11
• Study First Submitted: 2014-11-14
• Study First Submitted QC: 2014-11-29
• Study First Posted: 2014-12-03
• Last Update Submitted: 2015-05-21
• Last Update Posted: 2015-05-22
• Primary Completion: 2016-01
• Study Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in glucose	An expected duration which estimated to be average of 4.2 years	Fasting blood-glucose，1 and 2 hour postprandial blood glucose will be performed in order to diagnose patients with impaired fasting glucose, impaired glucose tolerance and diabetes according to 2006 World Health organization diagnostic criteria.
Change in C-Peptide	An expected duration which estimated to be average of 4.2 years	Fasting C-Peptide，1 and 2 hour postprandial C-Peptide will be performed in order to test pancreatic β-cell function.
Change in the Levels of fecal elastase-1	An expected duration which estimated to be average of 4.2 years	Fecal elastase-1(FE-1) were used to evaluate exocrine function. Exocrine insufficiency is defines as FE-1 level less than 200 Kg/g
Change in blood liquid	An expected duration which estimated to be average of 4.2 years	Blood liquid(triglyceride, cholesterol, low density lipoprotein and high-density lipoprotein) will be tested aiming at evaluating blood liquid metabolism.

Secondary Outcome Measures

Name	Time	Method
the MOS item short from health survey, SF-36	An expected duration which estimated to be average of 4.2 years	To make health study of acute pancreatitis patients through SF-36 for patients fpr patients with PaO2/FiO2\<200.
Abdomen CT	An expected duration which estimated to be average of 4.2 years	Abdomen CT(preferably enhancing) will be performed for each patient. If CT provides images of pancreatic calcification, pseudocyst, and irregular dilations of the pancreatic ducts, irregular borderline or shape of pancreas and so on, then chronic pancreatitis is suspected; If CT provides images of mass, then further examination should be performed to exclude pancreatic cancer. If CT shows diffuse enlargement with delayed enhancement(sometimes associated with rim-like enhancement) and segmental/focal enlargement with delayed enhancement, then autoimmune pancreatitis should be suspected. Pancreatic disease-associated portal hypertension is suspected if CT indicates splenomegaly and/or portal vein becomes broader.Furthermore, local complications of acute pancreatitis(pancreatic pseudocyst, and walled-off necrosis )according to 2012 revision of the Atlanta classification and definition by international consensus are also observed.
outpatient clinic and phone questionnaire	An expected duration which estimated to be average of 4.2 years

Trial Locations

Locations (1)

the First Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China