An Observational Study on the Natural Course of Chronic Pancreatitis
The Impact of Genetic and Environmental Factors on the Progression of Chronic Pancreatitis：An Observational Study
1 other identifier
observational
798
0 countries
N/A
Brief Summary
To explore the impact on genetic and environmental factors for clinical manifestation, and the progression of chronic pancreatitis, including development of pancreatic insufficiency and other complications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2011
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2020
CompletedFirst Submitted
Initial submission to the registry
September 27, 2020
CompletedFirst Posted
Study publicly available on registry
October 5, 2020
CompletedResults Posted
Study results publicly available
November 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
ExpectedNovember 30, 2021
October 1, 2021
9.4 years
September 27, 2020
September 1, 2021
October 25, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
the Number of Patients Developing Pancreatic Insufficiency
The primary endpoint was the number of patients developing pancreatic insufficiency, categorised as 1) diabetes and steatorrhea, 2) diabetes only, or 3) steatorrhea only.
10 years
Secondary Outcomes (1)
Death
20 years
Interventions
documenting the change of smoking and drinking status during the follow-up period
sequencing the susceptibility genes for CP, including serine protease inhibitor Kazal type 1, cationic trypsinogen, cystic fibrosis transmembrane conductance regulator, chymotrypsin C, etc.
Eligibility Criteria
Consequent patients with a diagnosis of CP in Changhai Hospital between 2010 to 2014
You may qualify if:
- patients with a diagnosis of chronic pancreatitis
- agree to join the study and provide informed consent
You may not qualify if:
- autoimmune pancreatitis
- pancreatic cancer diagnosed within 2 years after the diagnosis of chronic pancreatitis
- the follow-up time less than 2 years
- patients presenting with diabetes and/or steatorrhea at onset of CP.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Ru N, Xu XN, Cao Y, Zhu JH, Hu LH, Wu SY, Qian YY, Pan J, Zou WB, Li ZS, Liao Z. The Impacts of Genetic and Environmental Factors on the Progression of Chronic Pancreatitis. Clin Gastroenterol Hepatol. 2022 Jun;20(6):e1378-e1387. doi: 10.1016/j.cgh.2021.08.033. Epub 2021 Aug 28.
PMID: 34461303DERIVED
Biospecimen
The remained peripheral blood sample after laboratory examinations.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Zhuan Liao
- Organization
- Changhai Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 27, 2020
First Posted
October 5, 2020
Study Start
January 1, 2011
Primary Completion
May 31, 2020
Study Completion (Estimated)
December 31, 2030
Last Updated
November 30, 2021
Results First Posted
November 30, 2021
Record last verified: 2021-10