The Natural History of Chronic Pancreatitis

• Sponsor: Changhai Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03324698
• Collaborator: Shenzhen People's Hospital (Other), Zhongda Hospital (Other), Qingdao University (Other), Jiangdu Hospital of Traditional Chinese Medicine (Other), Yangzhou University (Other), 307 Hospital of PLA (Other), The First People's Hospital of Hefei (Other), Nanjing PLA General Hospital (Other), The Second Artillery General Hospital (Other), Wulumuqi General Hospital of Lanzhou Military Command (Other), Central Hospital of Zaozhuang Mining Group (Other), Air Force General Hospital of the PLA (Other)
• Enrollment: 4,000
• Location: 1
• Anticipated Duration (Months): 224
• Patients Per Site Per Month: 17.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

• Study Type: Observational
• Anticipated Enrollment: 4000 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: The Natural History of Chronic Pancreatitis: A Multicenter Study
• Actual Study Start Date: Jan 1, 2000
• Anticipated Primary Completion Date: Dec 31, 2017
• Anticipated Study Completion Date: Aug 31, 2018

Outcome Measures

Primary Outcome Measures

1. Pancreatic cancer [Dec 31, 2017]

   Pancreatic cancer developed in chronic pancreatitis patients

2. Diabetes mellitus [Dec 31, 2017]

   Endocrine insufficiency developed in chronic pancreatitis patients

3. Steatorrhea [Dec 31, 2017]

   Exocrine insufficiency developed in chronic pancreatitis patients

4. Pancreatic pseudocyst [Dec 31, 2017]

   Pancreatic pseudocyst developed in chronic pancreatitis patients

5. Common bile duct stricture [Dec 31, 2017]

   Common bile duct stricture developed in chronic pancreatitis patients

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Changhai Hospital, Second Military Medical University	Shanghai		China	200433

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Zhaoshen Li, Director of Gastroenterology Dept., Changhai Hospital
• ClinicalTrials.gov Identifier: NCT03324698
• Other Study ID Numbers: Changhai-171024
• First Posted: Oct 30, 2017
• Last Update Posted: Oct 30, 2017
• Last Verified: Oct 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pancreatitis; Pancreatitis, Chronic

Study Results

No Results Posted as of Oct 30, 2017