Follow-up Study of Complications of Acute Pancreatitis

NCT ID: NCT02305914

Last Updated: 2015-05-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-05-31

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.

Conditions

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

Study Groups

follow-up visit

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.

No interventions assigned to this group

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Nanchang University

OTHER

Sponsor Role: lead

Responsible Party

Lingyu Luo

Physician-in-charge

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nonghua Lv, MD

Role: STUDY_CHAIR

The First Affiliated Hospital of Nanchang University

Locations

the First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hongrong Xu, MD

Role: CONTACT

xuhr2009@163.com

15870649026

Lingyu Luo, MD

Role: CONTACT

15270855639@163.com

15270855639

Facility Contacts

Nonghua Lv, MD

Role: primary

lunonghua@163.com

13707086809

Kunhe Zhang, MD

Role: backup

393467260@qq.com

13007202818

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Related Links

http://www.cdyfy.com/

the First Affiliated Hospital of Nanchang University

Other Identifiers

FirstNanchangU

Identifier Type: -

Identifier Source: org_study_id