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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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 | An expected duration which estimated to be average of 4.2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongrong Xu, MD | Contact | 15870649026 | xuhr2009@163.com | |
| Lingyu Luo, MD | Contact | 15270855639 | 15270855639@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Nonghua Lv, MD | The First Affiliated Hospital of Nanchang University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | 330006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24694835 | Background | 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. | |
| 22885331 | Background | Peery 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. |
| Label | URL |
|---|---|
| the First Affiliated Hospital of Nanchang University | View source |
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010190 | Pancreatic Neoplasms |
| D008659 | Metabolic Diseases |
| D006975 | Hypertension, Portal |
| D012131 | Respiratory Insufficiency |
| D050500 | Pancreatitis, Chronic |
| D000081012 | Autoimmune Pancreatitis |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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Blood sample faeces sample
| 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. | An expected duration which estimated to be average of 4.2 years |
| outpatient clinic and phone questionnaire | An expected duration which estimated to be average of 4.2 years |
| 17533079 | Background | Papachristou 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. |
| 23300896 | Background | Urushihara 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. |
| 22668873 | Background | Xue 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. |
| 21705952 | Background | Wu 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. |
| 12890992 | Background | Boreham 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. |
| 23929695 | Background | Das 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. |
| 21068485 | Background | Khan AS, Latif SU, Eloubeidi MA. Controversies in the etiologies of acute pancreatitis. JOP. 2010 Nov 9;11(6):545-52. No abstract available. |
| 19407479 | Background | Anderson 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. |
| 18680239 | Background | Deng 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. |
| 15304116 | Background | Garg 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. |
| 16885867 | Background | Levy 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. |
| 11982735 | Background | Tandon 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. |
| 19034057 | Background | Wang 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. |
| 23890130 | Background | Rickels MR, Bellin M, Toledo FG, Robertson RP, Andersen DK, Chari ST, Brand R, Frulloni L, Anderson MA, Whitcomb DC; PancreasFest Recommendation Conference Participants. Detection, evaluation and treatment of diabetes mellitus in chronic pancreatitis: recommendations from PancreasFest 2012. Pancreatology. 2013 Jul-Aug;13(4):336-42. doi: 10.1016/j.pan.2013.05.002. Epub 2013 May 17. |
| 24389306 | Background | Bang UC, Benfield T, Hyldstrup L, Bendtsen F, Beck Jensen JE. Mortality, cancer, and comorbidities associated with chronic pancreatitis: a Danish nationwide matched-cohort study. Gastroenterology. 2014 Apr;146(4):989-94. doi: 10.1053/j.gastro.2013.12.033. Epub 2013 Dec 31. |
| 21412117 | Background | Shimosegawa T, Chari ST, Frulloni L, Kamisawa T, Kawa S, Mino-Kenudson M, Kim MH, Kloppel G, Lerch MM, Lohr M, Notohara K, Okazaki K, Schneider A, Zhang L; International Association of Pancreatology. International consensus diagnostic criteria for autoimmune pancreatitis: guidelines of the International Association of Pancreatology. Pancreas. 2011 Apr;40(3):352-8. doi: 10.1097/MPA.0b013e3182142fd2. |
| 25278307 | Background | Ikeura T, Miyoshi H, Uchida K, Fukui T, Shimatani M, Fukui Y, Sumimoto K, Matsushita M, Takaoka M, Okazaki K. Relationship between autoimmune pancreatitis and pancreatic cancer: a single-center experience. Pancreatology. 2014 Sep-Oct;14(5):373-9. doi: 10.1016/j.pan.2014.04.029. Epub 2014 Apr 21. |
| 22767586 | Background | Duell EJ, Lucenteforte E, Olson SH, Bracci PM, Li D, Risch HA, Silverman DT, Ji BT, Gallinger S, Holly EA, Fontham EH, Maisonneuve P, Bueno-de-Mesquita HB, Ghadirian P, Kurtz RC, Ludwig E, Yu H, Lowenfels AB, Seminara D, Petersen GM, La Vecchia C, Boffetta P. Pancreatitis and pancreatic cancer risk: a pooled analysis in the International Pancreatic Cancer Case-Control Consortium (PanC4). Ann Oncol. 2012 Nov;23(11):2964-2970. doi: 10.1093/annonc/mds140. Epub 2012 Jul 5. |
| 24998582 | Background | Tong GX, Geng QQ, Chai J, Cheng J, Chen PL, Liang H, Shen XR, Wang DB. Association between pancreatitis and subsequent risk of pancreatic cancer: a systematic review of epidemiological studies. Asian Pac J Cancer Prev. 2014;15(12):5029-34. doi: 10.7314/apjcp.2014.15.12.5029. |
| 15906778 | Background | Koklu S, Yuksel O, Arhan M, Coban S, Basar O, Yolcu OF, Ucar E, Ibis M, Ertugrul I, Sahin B. Report of 24 left-sided portal hypertension cases: a single-center prospective cohort study. Dig Dis Sci. 2005 May;50(5):976-82. doi: 10.1007/s10620-005-2674-x. |
| 20584644 | Background | Xu LS, Liu JH, Lin P, Huang KH, Chen QK, Chen YT, Zhu ZH. [Clinical features of panereatic disease-associated portal hypertension]. Nan Fang Yi Ke Da Xue Xue Bao. 2010 Jun;30(6):1234-6. Chinese. |
| 21470008 | Background | Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802. |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004700 | Endocrine System Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D008107 | Liver Diseases |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D044882 | Glucose Metabolism Disorders |