An Observational Study on the Natural Course of Chronic Pancreatitis

October 25, 2021 updated by: Zhuan Liao, Changhai Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

798

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consequent patients with a diagnosis of CP in Changhai Hospital between 2010 to 2014

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: 20 years
all-cause death
20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2011

Primary Completion (ACTUAL)

May 31, 2020

Study Completion (ANTICIPATED)

December 31, 2030

Study Registration Dates

First Submitted

September 27, 2020

First Submitted That Met QC Criteria

September 30, 2020

First Posted (ACTUAL)

October 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 30, 2021

Last Update Submitted That Met QC Criteria

October 25, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-2011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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