Natural Course and Therapeutic Effect of Chronic Pancreatitis

April 12, 2025 updated by: Zhaoshen Li, Changhai Hospital

Natural Course and Therapeutic Effect of Chronic Pancreatitis: a Prospect Cohort Study

The goal of this observational study is to establish a prospective cohort of chronic pancreatitis (CP) patients to provide evidence-based guidance for clinical practice and comprehensively optimize diagnostic and treatment strategies. The study aims to collect detailed demographic information, clinical data, medical imaging, biological samples, and follow-up information from CP patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Chronic pancreatitis (CP) is clinically characterized by abdominal pain and pancreatic dysfunction, including diabetes and steatorrhea, which significantly impact patients' quality of life and life expectancy. Globally, the annual incidence of CP is 9.62 per 100,000 individuals, with a mortality rate of 0.09 per 100,000 and a prevalence ranging from 13.5 to 560 per 100,000. In China, the prevalence of CP has also been increasing annually, currently reaching 13.52 per 100,000 individuals. In most countries worldwide, the incidence and prevalence of CP are generally on the rise, leading to an increasing healthcare burden. Due to the endocrine and exocrine functions of the pancreas, CP presents with highly variable clinical symptoms, diverse complications, and a risk of malignant transformation. Therefore, establishing a standardized, large-scale, long-term follow-up prospective cohort for CP is crucial for a more comprehensive understanding of its clinical characteristics and for providing high-quality evidence-based medical guidance for clinical practice.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Changhai Hospital
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Chronic pancreatitis patients in China.

Description

Inclusion Criteria:

  • Patients diagnosed with chronic pancreatitis.

Exclusion Criteria:

  • Patients who refuse to sign informed consent.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
chronic pancreatitis
This group included all enrolled patients with CP.
Other: Observation
Based on the patient's specific clinical condition, the appropriate examination and treatment in accordance with the conventional diagnosis and treatment standards of CP will be performed, including but not limited to: CT, MRI, endoscopic ultrasound (EUS) with or without biopsy, endocrine hormone testing (such as oral glucose tolerance test or mixed meal tolerance testing), pancreatic exocrine function tests (such as fecal elastase-1 test), extracorporeal shock wave lithotripsy (ESWL), endoscopic retrograde cholangiopancreatography (ERCP), and pancreatic enzyme replacement therapy. Patients were followed up regularly.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of complications
Time Frame: Annually for 10 years post-enrollment (Year 1 through Year 10)
The incidence of complications after the diagnosis of chronic pancreatitis, including diabetes mellitus, pancreatic exocrine insufficiency, pancreatic pseudocyst, biliary stricture, pancreatic portal hypertension, and pancreatic fistula.
Annually for 10 years post-enrollment (Year 1 through Year 10)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of pancreatic cancer
Time Frame: 5 and 10 years after enrollment
The incidence of pancreatic cancer after the diagnosis of chronic pancreatitis
5 and 10 years after enrollment
Efficacy of endoscopic treatment
Time Frame: 1 year after treatment
Proportion of patients with chronic pancreatitis who had pain relief after conservative, endoscopic (ESWL and ERCP), or surgical treatment
1 year after treatment
Scores of quality of life
Time Frame: Annually for 10 years post-enrollment (Year 1 through Year 10)
Quality of life scores for patients with chronic pancreatitis are obtained using SF-36 (36-Item Short Form Health Survey) which contains 8 dimensions scored from 0 to 100 (standardized converted scores). The higher score means better function.
Annually for 10 years post-enrollment (Year 1 through Year 10)
HbA1c level
Time Frame: Baseline and Year 1 to Year 10 post-enrollment (annually)
Glycated hemoglobin (HbA1c) level measured in venous blood (unit: %).
Baseline and Year 1 to Year 10 post-enrollment (annually)
Blood glucose profile characteristics
Time Frame: Baseline and Year 1 to Year 10 post-enrollment (annually)
Blood glucose profile from mixed-meal glucose tolerance test (MMTT) and continuous glucose monitoring system (CGMS) (unit: mmol/L or mg/dL).
Baseline and Year 1 to Year 10 post-enrollment (annually)
Pancreatic and gut hormone levels
Time Frame: Baseline and Year 1 to Year 10 post-enrollment (annually)
Levels of specific pancreatic hormones (C-peptide, insulin, glucagon, etc.) and gut hormones (ghrelin, gastric inhibitory peptide, glucagon like peptide-1, etc.) measured in venous blood (unit: specify for each hormone).
Baseline and Year 1 to Year 10 post-enrollment (annually)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Changhai Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shanghai Changzheng Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Zhaoshen Li, M.D., 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 13, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2035

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2035

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CCPC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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