The Natural History of Chronic Pancreatitis

Chronic Pancreatitis Clinical Trial

Official title:

The Natural History of Chronic Pancreatitis: A Multicenter Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03324698
• Other study ID #: Changhai-171024
• Status: Active, not recruiting
• Phase: N/A
• First received: October 25, 2017
• Last updated: October 27, 2017
• Start date: January 1, 2000
• Est. completion date: August 31, 2018

Study information

• Verified date: October 2017
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Chronic pancreatitis (CP) is a disease characterized by inflammation and their replacement by fibrotic tissue. The destruction of pancreatic function and structure are the main complications. This retrospective-prospective, multicenter, cohort study was conducted. This study aimed to observe the natural history of CP in China, analyse the risk factors for CP complications, and establish individual predictions.

Description:

In order to track changes consistently throughout the course of CP and facilitate the evaluation and study of CP, a dedicated database, CP Database (version number 2.1, YINMA Information Technology Inc., Shanghai, China), was established to collect clinical data of CP patients who were admitted to our centers. Data befor CP Database established were retrospectively collected according to the electronic medical record system and complemented through telephone, letter, and e-mail inquiries. Data were prospectively collected since CP Database was established. The following information was documented in detail: demographic data (age, sex, birthplace, et al), course of CP, medical history, history of other diseases, smoking and alcohol history, family history of pancreatic diseases and diabetes mellitus (DM), laboratory and imaging findings, and treatment strategy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4000
• Est. completion date: August 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with chronic pancreatitis according to Asia-Pacific consensus

Exclusion Criteria:

• Pancreatic cancer diagnosed within 2 years after the diagnosis of chronic pancreatitis

• Groove pancreatitis

• Autoimmune pancreatitis

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Complication
• Pancreatitis
• Pancreatitis, Chronic
• Risk Factors

Locations

Country	Name	City	State
China	Changhai Hospital, Second Military Medical University	Shanghai

Sponsors (13)

Lead Sponsor

Collaborator

Changhai Hospital

307 Hospital of PLA, Air Force General Hospital of the PLA, Central Hospital of Zaozhuang Mining Group, Jiangdu Hospital of Traditional Chinese Medicine, Nanjing PLA General Hospital, Qingdao University, Shenzhen People's Hospital, The First People's Hospital of Hefei, The Second Artillery General Hospital, Wulumuqi General Hospital of Lanzhou Military Command, Yangzhou University, Zhongda Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

Hao L, Bi YW, Zhang D, Zeng XP, Xin L, Pan J, Wang D, Ji JT, Du TT, Lin JH, Ye B, Zou WB, Chen H, Xie T, Li BR, Zheng ZH, Wang T, Guo HL, Liao Z, Li ZS, Hu LH. Risk Factors and Nomogram for Common Bile Duct Stricture in Chronic Pancreatitis: A Cohort of 2153 Patients. J Clin Gastroenterol. 2017 Sep 28. doi: 10.1097/MCG.0000000000000930. [Epub ahead of print] — View Citation

Hao L, Pan J, Wang D, Bi YW, Ji JT, Xin L, Liao Z, Du TT, Lin JH, Zhang D, Zeng XP, Ye B, Zou WB, Chen H, Xie T, Li BR, Zheng ZH, Hu LH, Li ZS. Risk factors and nomogram for pancreatic pseudocysts in chronic pancreatitis: A cohort of 1998 patients. J Gastroenterol Hepatol. 2017 Jul;32(7):1403-1411. doi: 10.1111/jgh.13748. — View Citation

Hao L, Zeng XP, Xin L, Wang D, Pan J, Bi YW, Ji JT, Du TT, Lin JH, Zhang D, Ye B, Zou WB, Chen H, Xie T, Li BR, Zheng ZH, Wang T, Guo HL, Liao Z, Li ZS, Hu LH. Incidence of and risk factors for pancreatic cancer in chronic pancreatitis: A cohort of 1656 patients. Dig Liver Dis. 2017 Nov;49(11):1249-1256. doi: 10.1016/j.dld.2017.07.001. Epub 2017 Jul 15. — View Citation

Li BR, Pan J, Du TT, Liao Z, Ye B, Zou WB, Chen H, Ji JT, Zheng ZH, Wang D, Lin JH, Ning SB, Hu LH, Li ZS. Risk Factors for Steatorrhea in Chronic Pancreatitis: A Cohort of 2,153 Patients. Sci Rep. 2016 Feb 15;6:21381. doi: 10.1038/srep21381. — View Citation

Pan J, Xin L, Wang D, Liao Z, Lin JH, Li BR, Du TT, Ye B, Zou WB, Chen H, Ji JT, Zheng ZH, Hu LH, Li ZS. Risk Factors for Diabetes Mellitus in Chronic Pancreatitis: A Cohort of 2011 Patients. Medicine (Baltimore). 2016 Apr;95(14):e3251. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pancreatic cancer	Pancreatic cancer developed in chronic pancreatitis patients	Dec 31, 2017
Primary	Diabetes mellitus	Endocrine insufficiency developed in chronic pancreatitis patients	Dec 31, 2017
Primary	Steatorrhea	Exocrine insufficiency developed in chronic pancreatitis patients	Dec 31, 2017
Primary	Pancreatic pseudocyst	Pancreatic pseudocyst developed in chronic pancreatitis patients	Dec 31, 2017
Primary	Common bile duct stricture	Common bile duct stricture developed in chronic pancreatitis patients	Dec 31, 2017