Follow-up Study of Complications of Acute Pancreatitis

Quality of Life Clinical Trial

— FSCAP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02305914
• Other study ID #: FirstNanchangU
• Status: Recruiting
• Phase: N/A
• First received: November 14, 2014
• Last updated: May 21, 2015
• Start date: November 2014
• Est. completion date: May 2016

Study information

• Verified date: November 2014
• Source: The First Affiliated Hospital of Nanchang University
• Contact: Hongrong Xu, MD
• Phone: 15870649026
• Email: xuhr2009[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1300
• Est. completion date: May 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Nanchang University

Country where clinical trial is conducted

China, 

References & Publications (24)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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):2964-70. doi: 10.1093/annonc/mds140. Epub 2012 Jul 5. — View Citation

Garg PK, Tandon RK. Survey on chronic pancreatitis in the Asia-Pacific region. J Gastroenterol Hepatol. 2004 Sep;19(9):998-1004. — View Citation

Herridge MS, Tansey CM, Matté 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. — View Citation

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. — View Citation

Khan AS, Latif SU, Eloubeidi MA. Controversies in the etiologies of acute pancreatitis. JOP. 2010 Nov 9;11(6):545-52. Review. — View Citation

Köklü S, Yüksel O, Arhan M, Coban S, Basar O, Yolcu OF, Uçar 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. — View Citation

Lévy 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. — View Citation

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. — View Citation

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. Review. — View Citation

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):1179-87.e1-3. doi: 10.1053/j.gastro.2012.08.002. Epub 2012 Aug 8. — View Citation

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. — View Citation

Shimosegawa T, Chari ST, Frulloni L, Kamisawa T, Kawa S, Mino-Kenudson M, Kim MH, Klöppel G, Lerch MM, Löhr 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. — View Citation

Tandon RK, Sato N, Garg PK; Consensus Study Group. Chronic pancreatitis: Asia-Pacific consensus report. J Gastroenterol Hepatol. 2002 Apr;17(4):508-18. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Change in C-Peptide	Fasting C-Peptide,1 and 2 hour postprandial C-Peptide will be performed in order to test pancreatic ß-cell function.	An expected duration which estimated to be average of 4.2 years	No
Primary	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	No
Primary	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	No
Secondary	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.	An expected duration which estimated to be average of 4.2 years	No
Secondary	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	No
Secondary	outpatient clinic and phone questionnaire		An expected duration which estimated to be average of 4.2 years	No

External Links

•   the First Affiliated Hospital of Nanchang University