The Natural History of Chronic Pancreatitis

The Natural History of Chronic Pancreatitis: A Multicenter Study

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Pancreatitis; Complication; Risk Factors

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 4000

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200433
    • Changhai Hospital, Second Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Chronic pancreatitis patients in China

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pancreatic cancer	Pancreatic cancer developed in chronic pancreatitis patients	Dec 31, 2017
Diabetes mellitus	Endocrine insufficiency developed in chronic pancreatitis patients	Dec 31, 2017
Steatorrhea	Exocrine insufficiency developed in chronic pancreatitis patients	Dec 31, 2017
Pancreatic pseudocyst	Pancreatic pseudocyst developed in chronic pancreatitis patients	Dec 31, 2017
Common bile duct stricture	Common bile duct stricture developed in chronic pancreatitis patients	Dec 31, 2017

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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. 2019 Mar;53(3):e91-e100. doi: 10.1097/MCG.0000000000000930.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2000
• Primary Completion (Anticipated): December 31, 2017
• Study Completion (Anticipated): August 31, 2018

Study Registration Dates

• First Submitted: October 25, 2017
• First Submitted That Met QC Criteria: October 27, 2017
• First Posted (Actual): October 30, 2017

Study Record Updates

• Last Update Posted (Actual): October 30, 2017
• Last Update Submitted That Met QC Criteria: October 27, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Pancreatitis, Chronic
• Other Study ID Numbers: Changhai-171024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No