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The Natural History of Chronic Pancreatitis

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ClinicalTrials.gov Identifier: NCT03324698
Recruitment Status : Active, not recruiting
First Posted : October 30, 2017
Last Update Posted : October 30, 2017
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Zhaoshen Li, Changhai Hospital

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
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
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Natural History of Chronic Pancreatitis: A Multicenter Study
Actual Study Start Date : January 1, 2000
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis




Primary Outcome Measures :
  1. Pancreatic cancer [ Time Frame: Dec 31, 2017 ]
    Pancreatic cancer developed in chronic pancreatitis patients

  2. Diabetes mellitus [ Time Frame: Dec 31, 2017 ]
    Endocrine insufficiency developed in chronic pancreatitis patients

  3. Steatorrhea [ Time Frame: Dec 31, 2017 ]
    Exocrine insufficiency developed in chronic pancreatitis patients

  4. Pancreatic pseudocyst [ Time Frame: Dec 31, 2017 ]
    Pancreatic pseudocyst developed in chronic pancreatitis patients

  5. Common bile duct stricture [ Time Frame: Dec 31, 2017 ]
    Common bile duct stricture developed in chronic pancreatitis patients



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Chronic pancreatitis patients in China
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03324698


Locations
China
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

Publications:

Responsible Party: Zhaoshen Li, Director of Gastroenterology Dept., Changhai Hospital
ClinicalTrials.gov Identifier: NCT03324698     History of Changes
Other Study ID Numbers: Changhai-171024
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 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
Pancreatic Diseases
Digestive System Diseases