Natural Course and Therapeutic Effect of Recurrent Acute Pancreatitis (NACRE)

April 3, 2024 updated by: Zhaoshen Li, Changhai Hospital

Natural Course and Therapeutic Effect of Recurrent Acute Pancreatitis: a Prospective Cohort Study

The goal of this observational cohort study is to learn about the etiology, natural course, therapeutic effect and outcome of recurrent acute pancreatitis patients. The main question it aims to answer is:

Does endoscopic intervention, surgery or conservative treatment reduce the recurrence of acute pancreatitis? What are the risk factors affecting the recurrence of acute pancreatitis?

Patients will be closely followed and clinical information will be recorded.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Acute pancreatitis is one of the most common causes of acute hospital admission, which is unpredictable and contributes to high health-care costs even death. Recurrent acute pancreatitis is defined as two or more discrete episodes of acute pancreatitis, and has an estimated annual incidence of 8-10 per 100 000. Cholelithiasis, alcohol and Hyperglyceremia are the most commonly recognized causes of acute pancreatitis. About 80% of RAP patients can be identified through routine investigations identify (include proper history, physical examination, CT, MRI, endoscopic ultrasound); however, in up to 20% of cases whose cause remains unclear are known as idiopathic RAP. For RAP patients with clear cause, removal of the cause can effectively reduce or prevent recurrence. For patients with idiopathic RAP, the treatment options are not clear and have been subject to debate. At present, the natural course, outcome and therapeutic effect of RAP is still not clear. Therefore, the prospective cohort can clarify the clinical characteristics of RAP more comprehensively and deeply and to accumulate evidence for treatment.

Study Type

Observational

Enrollment (Estimated)

2000

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

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients whti recurrent acute pancreatitis come from Changhai Hospital.

Description

Inclusion Criteria:

  • Patients with recurrent acute pancreatitis.

Exclusion Criteria:

  • Unwilling or unable to provide 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
Intervention / Treatment
recurrent acute pancreatitis
Recurrent acute pancreatitis is generally defined as a condition in which at least two well documented episodes of acute pancreatitis have occurred, with resolution of symptoms between each episode, and absence of morphological criteria for chronic pancreatitis.
Combination product: endoscopic intervention, surgery or conservative treatment
Personal information and treatment of the enrolled subjects will be collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence rate of acute pancreatitis
Time Frame: Through study completion, an average of 1 year
Acute pancreatitis is diagnosed according to the revised Atlanta classification, which requires 2 of the 3 following criteria: (1) abdominal pain suggestive of pancreatitis, (2) serum amylase and/or lipase greater than 3 times the upper limit of normal, (3) and crosssectional imaging (CT or MRI) findings consistent with acute pancreatitis.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with different treatment
Time Frame: Through study completion, an average of 1 year
Treatment mainly contains conservative treatment, surgery, endoscopic intervention, etc. Collect relevant data through medical record.
Through study completion, an average of 1 year
Characteristics of acute pancreatitis
Time Frame: Through study completion, an average of 1 year
Collect relevant data through medical record. Characteristics of acute pancreatitis includ etiology, frequency, severity and length of hospital.
Through study completion, an average of 1 year
Proportion of patients wtih pain in RAP patients
Time Frame: Through study completion, an average of 3 year
Collect relevant data through pain assessment scales which include severity, frequency, time of duration and other characteristics of pancreatic pain.
Through study completion, an average of 3 year
Proportion of patients with chronic pancreatitis
Time Frame: Through study completion, an average of 3 year
Proportion of patients who developed chronic pancreatitis.
Through study completion, an average of 3 year
Evaluation of quality of life
Time Frame: Through study completion, an average of 3 year
The level of quality of life in RAP patients is measured using the SF-36.
Through study completion, an average of 3 year
Evaluation of psychological condition
Time Frame: Through study completion, an average of 3 year
The psychological condition of RAP patients is measured using DASS-21.
Through study completion, an average of 3 year

Collaborators and Investigators

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

Sponsor

Changhai Hospital

Investigators

  • Study Chair: Zhaoshen Li, M.D., Changhai Hospital

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 (Estimated)

April 1, 2024

Primary Completion (Estimated)

December 1, 2034

Study Completion (Estimated)

December 1, 2034

Study Registration Dates

First Submitted

March 28, 2024

First Submitted That Met QC Criteria

April 3, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NACRE20230306

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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