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Active, Not Recruiting

NCT Number: NCT04574297

An Observational Study on the Natural Course of Chronic Pancreatitis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chronic Pancreatitis Alcohol Drinking Behavior Chronic Disease Digestive System Diseases Disease Attributes Drinking Behavior Drinking, Alcohol Genetic Mutation Pancreatic Diseases Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms Smoking Smoking, Tobacco Tobacco Smoking Tobacco Use

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

smoking and alcohol assumption

Behavioral

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

genetic sequencing

Diagnostic Test

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

Primary outcomes

  1. the Number of Patients Developing Pancreatic Insufficiency

    Time frame: 10 years

    The primary endpoint was the number of patients developing pancreatic insufficiency, categorised as 1) diabetes and steatorrhea, 2) diabetes only, or 3) steatorrhea only.

Secondary outcomes

  1. Death

    Time frame: 20 years

    all-cause death

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

The Impact of Genetic and Environmental Factors on the Progression of Chronic Pancreatitis：An Observational Study

Important dates

Study start
2011
Primary completion
2020
Study completion
2030
First posted
Oct 5, 2020
Registry last updated
Nov 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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