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Follow-up Study of Complications of Acute Pancreatitis (FSCAP)

N

Nanchang University

Status

Unknown

Conditions

Hypertension, Portal
Metabolic Diseases
Respiratory Failure
Quality of Life
Pancreatitis
Pancreatic Neoplasms

Study type

Observational

Funder types

Other

Identifiers

NCT02305914
FirstNanchangU

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,300 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

1,300 participants in 1 patient group

follow-up visit
Description:
Patients who come for follow-up visit will fill in the questionnaire and undergo regular laboratory examination such as liver function test and CRP,faecal elastase-1 as well as CT scanning.Additionally,blood sample of every patient will be collected and sent to the Lab for storage and further experimented.

Trial contacts and locations

1

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Central trial contact

Hongrong Xu, MD; Lingyu Luo, MD

Data sourced from clinicaltrials.gov

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