Clinical trial NCT03324698: The Natural History of Chronic Pancreatitis
Official title: The Natural History of Chronic Pancreatitis: A Multicenter Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pancreatitis
Complication
Risk Factors
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Shenzhen People's Hospital
name: Zhongda Hospital
name: Qingdao University
name: Jiangdu Hospital of Traditional Chinese Medicine
name: Yangzhou University
name: 307 Hospital of PLA
name: The First People's Hospital of Hefei
name: Nanjing PLA General Hospital
name: The Second Artillery General Hospital
name: Wulumuqi General Hospital of Lanzhou Military Command
name: Central Hospital of Zaozhuang Mining Group
name: Air Force General Hospital of the PLA
First posted: 2017-10-30
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chronic pancreatitis patients in China

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pancreatic cancer
timeFrame: Dec 31, 2017
measure: Diabetes mellitus
timeFrame: Dec 31, 2017
measure: Steatorrhea
timeFrame: Dec 31, 2017
measure: Pancreatic pseudocyst
timeFrame: Dec 31, 2017
measure: Common bile duct stricture
timeFrame: Dec 31, 2017
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital, Second Military Medical University
Study officials:
References:
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.
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.
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.
citation: 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.