PancreatitisFSCAPNCT02305914
Follow-up Study of Complications of Acute Pancreatitis
An observational study of Pancreatitis and Pancreatic Neoplasms, run by The First Affiliated Hospital of Nanchang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatitis, Pancreatic Neoplasms, Metabolic Diseases
- How many people
- 1,300 participants
- Where
- 1 siteChina
- Study dates
- Nov 2014to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Clinical diagnosis of acute pancreatitis from our hospital
- Must be signed the informed consent
Who cannot join
- Failed to complete the questionnaire survey and the follow-up examination
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Nonghua Lv, MD, 13707086809, lunonghua@163.com
Kunhe Zhang, MD, 13007202818, 393467260@qq.com
About this study
Official title: A Large Sample Follow-up Study of Long-term Complications of Acute Pancreatitis
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.
Read the 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
- 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
- Medical subject headings
- Pancreatitis, Pancreatic Neoplasms, Metabolic Diseases, Hypertension, Portal, Respiratory Insufficiency, Pancreatitis, Chronic, Autoimmune Pancreatitis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: An expected duration which estimated to be average of 4.2 years
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.
Measured: An expected duration which estimated to be average of 4.2 years
Change in blood liquid
Blood liquid(triglyceride, cholesterol, low density lipoprotein and high-density lipoprotein) will be tested aiming at evaluating blood liquid metabolism.
Measured: An expected duration which estimated to be average of 4.2 years
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
Measured: An expected duration which estimated to be average of 4.2 years
Secondary outcomes (3)
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.
Measured: An expected duration which estimated to be average of 4.2 years
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.
Measured: An expected duration which estimated to be average of 4.2 years
outpatient clinic and phone questionnaire
Measured: An expected duration which estimated to be average of 4.2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionJan 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Nanchang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lingyu Luo, The First Affiliated Hospital of Nanchang University
- Investigators
- Nonghua Lv, MD, Study chair, The First Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305914
- Sponsor's protocol ID
- FirstNanchangU
- Acronym
- FSCAP
- Status last verified
- Nov 2014
- First submitted
- 14 Nov 2014
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
McNabb-Baltar J, Ravi P, Isabwe GA, Suleiman SL, Yaghoobi M, Trinh QD, Banks PA. A population-based assessment of the burden of acute pancreatitis in the United States. Pancreas. 2014 Jul;43(5):687-91. doi: 10.1097/MPA.0000000000000123.
PubMed 24694835Peery AF, Dellon ES, Lund J, Crockett SD, McGowan CE, Bulsiewicz WJ, Gangarosa LM, Thiny MT, Stizenberg K, Morgan DR, Ringel Y, Kim HP, DiBonaventura MD, Carroll CF, Allen JK, Cook SF, Sandler RS, Kappelman MD, Shaheen NJ. Burden of gastrointestinal disease in the United States: 2012 update. Gastroenterology. 2012 Nov;143(5):1179-1187.e3. doi: 10.1053/j.gastro.2012.08.002. Epub 2012 Aug 8.
PubMed 22885331Papachristou GI, Clermont G, Sharma A, Yadav D, Whitcomb DC. Risk and markers of severe acute pancreatitis. Gastroenterol Clin North Am. 2007 Jun;36(2):277-96, viii. doi: 10.1016/j.gtc.2007.03.003.
PubMed 17533079Urushihara H, Taketsuna M, Liu Y, Oda E, Nakamura M, Nishiuma S, Maeda R. Increased risk of acute pancreatitis in patients with type 2 diabetes: an observational study using a Japanese hospital database. PLoS One. 2012;7(12):e53224. doi: 10.1371/journal.pone.0053224. Epub 2012 Dec 27.
PubMed 23300896Xue Y, Sheng Y, Dai H, Cao H, Liu Z, Li Z. Risk of development of acute pancreatitis with pre-existing diabetes: a meta-analysis. Eur J Gastroenterol Hepatol. 2012 Sep;24(9):1092-8. doi: 10.1097/MEG.0b013e328355a487.
PubMed 22668873Wu D, Xu Y, Zeng Y, Wang X. Endocrine pancreatic function changes after acute pancreatitis. Pancreas. 2011 Oct;40(7):1006-11. doi: 10.1097/MPA.0b013e31821fde3f.
PubMed 21705952Boreham B, Ammori BJ. A prospective evaluation of pancreatic exocrine function in patients with acute pancreatitis: correlation with extent of necrosis and pancreatic endocrine insufficiency. Pancreatology. 2003;3(4):303-8. doi: 10.1159/000071768.
PubMed 12890992Das SL, Singh PP, Phillips AR, Murphy R, Windsor JA, Petrov MS. Newly diagnosed diabetes mellitus after acute pancreatitis: a systematic review and meta-analysis. Gut. 2014 May;63(5):818-31. doi: 10.1136/gutjnl-2013-305062. Epub 2013 Aug 8.
PubMed 23929695Khan AS, Latif SU, Eloubeidi MA. Controversies in the etiologies of acute pancreatitis. JOP. 2010 Nov 9;11(6):545-52. No abstract available.
PubMed 21068485Anderson F, Thomson SR, Clarke DL, Buccimazza I. Dyslipidaemic pancreatitis clinical assessment and analysis of disease severity and outcomes. Pancreatology. 2009;9(3):252-7. doi: 10.1159/000212091. Epub 2009 Apr 29.
PubMed 19407479Deng LH, Xue P, Xia Q, Yang XN, Wan MH. Effect of admission hypertriglyceridemia on the episodes of severe acute pancreatitis. World J Gastroenterol. 2008 Jul 28;14(28):4558-61. doi: 10.3748/wjg.14.4558.
PubMed 18680239Garg PK, Tandon RK. Survey on chronic pancreatitis in the Asia-Pacific region. J Gastroenterol Hepatol. 2004 Sep;19(9):998-1004. doi: 10.1111/j.1440-1746.2004.03426.x.
PubMed 15304116Levy P, Barthet M, Mollard BR, Amouretti M, Marion-Audibert AM, Dyard F. Estimation of the prevalence and incidence of chronic pancreatitis and its complications. Gastroenterol Clin Biol. 2006 Jun-Jul;30(6-7):838-44. doi: 10.1016/s0399-8320(06)73330-9.
PubMed 16885867Tandon RK, Sato N, Garg PK; Consensus Study Group. Chronic pancreatitis: Asia-Pacific consensus report. J Gastroenterol Hepatol. 2002 Apr;17(4):508-18. doi: 10.1046/j.1440-1746.2002.02762.x.
PubMed 11982735Wang LW, Li ZS, Li SD, Jin ZD, Zou DW, Chen F. Prevalence and clinical features of chronic pancreatitis in China: a retrospective multicenter analysis over 10 years. Pancreas. 2009 Apr;38(3):248-54. doi: 10.1097/MPA.0b013e31818f6ac1.
PubMed 19034057
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Large Sample Follow-up Study of Long-term Complications of Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT02305914
- Acronym / sponsor ID
- FSCAP / FirstNanchangU
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jan 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 3 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Clinical diagnosis of acute pancreatitis from our hospital
- Must be signed the informed consent
Key exclusion criteria (1 listed)
- Failed to complete the questionnaire survey and the follow-up examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change in glucose
Time frame: 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
Time frame: 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 blood liquid
Time frame: 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.
Change in the Levels of fecal elastase-1
Time frame: 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
3 secondary outcomes
Abdomen CT
Time frame: An expected duration which estimated to be average of 4.2 years
the MOS item short from health survey, SF-36
Time frame: An expected duration which estimated to be average of 4.2 years
outpatient clinic and phone questionnaire
Time frame: An expected duration which estimated to be average of 4.2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
- Background: PubMed 24694835McNabb-Baltar J, Ravi P, Isabwe GA, Suleiman SL, Yaghoobi M, Trinh QD, Banks PA. A population-based assessment of the burden of acute pancreatitis in the United States. Pancreas. 2014 Jul;43(5):687-91. doi: 10.1097/MPA.0000000000000123.
- Background: PubMed 22885331Peery AF, Dellon ES, Lund J, Crockett SD, McGowan CE, Bulsiewicz WJ, Gangarosa LM, Thiny MT, Stizenberg K, Morgan DR, Ringel Y, Kim HP, DiBonaventura MD, Carroll CF, Allen JK, Cook SF, Sandler RS, Kappelman MD, Shaheen NJ. Burden of gastrointestinal disease in the United States: 2012 update. Gastroenterology. 2012 Nov;143(5):1179-1187.e3. doi: 10.1053/j.gastro.2012.08.002. Epub 2012 Aug 8.
- Background: PubMed 17533079Papachristou GI, Clermont G, Sharma A, Yadav D, Whitcomb DC. Risk and markers of severe acute pancreatitis. Gastroenterol Clin North Am. 2007 Jun;36(2):277-96, viii. doi: 10.1016/j.gtc.2007.03.003.
- Background: PubMed 23300896Urushihara H, Taketsuna M, Liu Y, Oda E, Nakamura M, Nishiuma S, Maeda R. Increased risk of acute pancreatitis in patients with type 2 diabetes: an observational study using a Japanese hospital database. PLoS One. 2012;7(12):e53224. doi: 10.1371/journal.pone.0053224. Epub 2012 Dec 27.
- Background: PubMed 22668873Xue Y, Sheng Y, Dai H, Cao H, Liu Z, Li Z. Risk of development of acute pancreatitis with pre-existing diabetes: a meta-analysis. Eur J Gastroenterol Hepatol. 2012 Sep;24(9):1092-8. doi: 10.1097/MEG.0b013e328355a487.
- Background: PubMed 21705952Wu D, Xu Y, Zeng Y, Wang X. Endocrine pancreatic function changes after acute pancreatitis. Pancreas. 2011 Oct;40(7):1006-11. doi: 10.1097/MPA.0b013e31821fde3f.
- Background: PubMed 12890992Boreham B, Ammori BJ. A prospective evaluation of pancreatic exocrine function in patients with acute pancreatitis: correlation with extent of necrosis and pancreatic endocrine insufficiency. Pancreatology. 2003;3(4):303-8. doi: 10.1159/000071768.
- Background: PubMed 23929695Das SL, Singh PP, Phillips AR, Murphy R, Windsor JA, Petrov MS. Newly diagnosed diabetes mellitus after acute pancreatitis: a systematic review and meta-analysis. Gut. 2014 May;63(5):818-31. doi: 10.1136/gutjnl-2013-305062. Epub 2013 Aug 8.
- Background: PubMed 21068485Khan AS, Latif SU, Eloubeidi MA. Controversies in the etiologies of acute pancreatitis. JOP. 2010 Nov 9;11(6):545-52. No abstract available.
- Background: PubMed 19407479Anderson F, Thomson SR, Clarke DL, Buccimazza I. Dyslipidaemic pancreatitis clinical assessment and analysis of disease severity and outcomes. Pancreatology. 2009;9(3):252-7. doi: 10.1159/000212091. Epub 2009 Apr 29.
- Background: PubMed 18680239Deng LH, Xue P, Xia Q, Yang XN, Wan MH. Effect of admission hypertriglyceridemia on the episodes of severe acute pancreatitis. World J Gastroenterol. 2008 Jul 28;14(28):4558-61. doi: 10.3748/wjg.14.4558.
- Background: PubMed 15304116Garg PK, Tandon RK. Survey on chronic pancreatitis in the Asia-Pacific region. J Gastroenterol Hepatol. 2004 Sep;19(9):998-1004. doi: 10.1111/j.1440-1746.2004.03426.x.
- the First Affiliated Hospital of Nanchang UniversityLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nonghua Lv, MD study chair
The First Affiliated Hospital of Nanchang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatitis and Pancreatic Neoplasms, run by The First Affiliated Hospital of Nanchang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongrong Xu, MD (15870649026, xuhr2009@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in glucose (time frame: An expected duration which estimated to be average of 4.2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02305914, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2015.