An Observational Study on the Natural Course of Chronic Pancreatitis

NCT ID: NCT04574297

Last Updated: 2021-11-30

Study Results

Results available

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

798 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-01

Study Completion Date

2030-12-31

Brief Summary

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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.

Detailed Description

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The present study was an observational study aimed to explore the impact of genetic factors (rare pathogenic variants of CP) and environmental factors(smoking and alcohol assumption) on the clinical manifestation and progression of CP. The observation items included the pain patterns, incidence of complications of CP, pancreatic cancer and death.

Conditions

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Chronic Pancreatitis Genetic Mutation Smoking, Tobacco Drinking, Alcohol

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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smoking and alcohol assumption

documenting the change of smoking and drinking status during the follow-up period

Intervention Type BEHAVIORAL

genetic sequencing

sequencing the susceptibility genes for CP, including serine protease inhibitor Kazal type 1, cationic trypsinogen, cystic fibrosis transmembrane conductance regulator, chymotrypsin C, etc.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* patients with a diagnosis of chronic pancreatitis
* agree to join the study and provide informed consent

Exclusion Criteria

* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhuan Liao

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 34461303 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CP-2011

Identifier Type: -

Identifier Source: org_study_id