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

Primary Purpose

Pancreatitis, Pancreatic Neoplasms, Metabolic Diseases

Status

Unknown status

Phase

Locations

China

Study Type

Observational

Intervention

About this trial

This is an observational trial for Pancreatitis focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

the First Affiliated Hospital of Nanchang UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Arm Label

follow-up visit

Arm 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.

Outcomes

Primary Outcome Measures

change in glucose

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

Fasting C-Peptide，1 and 2 hour postprandial C-Peptide will be performed in order to test pancreatic β-cell function.

Change in blood liquid

Blood liquid(triglyceride, cholesterol, low density lipoprotein and high-density lipoprotein) will be tested aiming at evaluating blood liquid metabolism.

Change in the Levels of fecal elastase-1

Fecal elastase-1(FE-1) were used to evaluate exocrine function. Exocrine insufficiency is defines as FE-1 level less than 200 Kg/g

Secondary Outcome Measures

Abdomen CT

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.

the MOS item short from health survey, SF-36

To make health study of acute pancreatitis patients through SF-36 for patients fpr patients with PaO2/FiO2<200.

outpatient clinic and phone questionnaire

Full Information

NCT ID

NCT02305914

First Posted

November 14, 2014

Last Updated

May 21, 2015

Sponsor

The First Affiliated Hospital of Nanchang University

1. Study Identification

Unique Protocol Identification Number

NCT02305914

Brief Title

Follow-up Study of Complications of Acute Pancreatitis

Acronym

FSCAP

Official Title

A Large Sample Follow-up Study of Long-term Complications of Acute Pancreatitis

Study Type

Observational

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Unknown status

Study Start Date

November 2014 (undefined)

Primary Completion Date

January 2016 (Anticipated)

Study Completion Date

May 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The First Affiliated Hospital of Nanchang University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Enrollment

1300 (Anticipated)

Biospecimen Retention

Samples With DNA

Biospecimen Description

Blood sample faeces sample

8. Arms, Groups, and Interventions

Arm Title

follow-up visit

Arm Description

Primary Outcome Measure Information:

Title

change in glucose

Description

Time Frame