Investigation on the Current Situation and Risk Factors Analysis of Exocrine Insufficiency in Chronic Pancreatitis (CP-ESRF)
April 23, 2025 updated by: Zhaoshen Li, Changhai Hospital
Investigation on the Current Situation and Risk Factors Analysis of Exocrine Insufficiency in Chronic Pancreatitis: A Prospective Cohort Investigation Study
Pancreatic exocrine insufficiency (PEI) is one of the common complications of chronic pancreatitis (CP).
Mild to moderate PEI may present with atypical digestive tract symptoms such as abdominal distension and abdominal pain, while severe PEI can lead to related complications such as foul-smelling stools, steatorrhea, weight loss, and malnutrition.
Currently, there is no relevant report on the status quo of PEI in Chinese CP patients.
This study aims to analyze the status quo of PEI and related risk factors in Chinese CP patients, with the hope of providing safe and effective intervention and treatment methods to improve the quality of life of patients.
Study Overview
Status
Completed
Detailed Description
Pancreatic exocrine insufficiency (PEI) is one of the common complications of chronic pancreatitis (CP).
Mild to moderate PEI may present with atypical digestive tract symptoms such as abdominal distension and abdominal pain, while severe PEI can lead to related complications such as foul-smelling stools, steatorrhea, weight loss, and malnutrition.
Currently, there is no relevant report on the status quo of PEI in Chinese CP patients.This study aims to analyze the current status and related risk factors of PEI in CP patients in China by detecting pancreatic exocrine function with FE-1, in order to provide safe and effective intervention and treatment methods and improve the quality of life of patients.
Study Type
Observational
Enrollment (Actual)
1101
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200433
- Changhai Hospital
-
-
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
This hospital-based cohort study enrolled patients diagnosed with chronic pancreatitis (CP) who underwent inpatient care at Shanghai Changhai Hospital (a WHO Collaborating Center for Pancreatology) between June 2022 and September 2024
Description
Inclusion Criteria:
- patients who underwent inpatient care at Shanghai Changhai Hospital (a WHO Collaborating Center for Pancreatology) between June 2022 and September 2024.
- patients diagnosed with chronic pancreatitis (CP)
- Voluntarily preserve feces for the detection of fecal elastase-1 (FE-1)
Exclusion Criteria:
- Patients who were diagnosed with pancreatic cancer within 2 years after being diagnosed with chronic pancreatitis (CP)
- patients with groove pancreatitis,
- patients with autoimmune pancreatitis.
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 |
|---|---|
|
the patients diagnosed with chronic pancreatitis who underwent inpatient care
This hospital-based cohort study enrolled patients diagnosed with chronic pancreatitis (CP) who underwent inpatient care at Shanghai Changhai Hospital (a WHO Collaborating Center for Pancreatology) between June 2022 and September 2024,Voluntary retention of fecal samples for FE-1 detection in CP patients
|
For CP patients who are hospitalized, they are recruited to voluntarily preserve their feces for the detection of fecal elastase-1 (FE-1) so as to evaluate the pancreatic exocrine function.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Detection of Pancreatic Exocrine Function in CP Patients
Time Frame: Day 1
|
For CP patients who are hospitalized, they are recruited to voluntarily preserve their feces for the detection of fecal elastase-1 (FE-1) so as to evaluate the pancreatic exocrine function.
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The demographic information of the patients
Time Frame: Day 1
|
The gender（male/female）, age, height（cm） and weight（kg） upon admission, history of smoking and drinking, family medical history, etc. of the patients with chronic pancreatitis （Only occurrences were recorded as occurring or not occurring）
|
Day 1
|
|
The information of the patients' natural disease course
Time Frame: Day 1
|
The age of onset of chronic pancreatitis (CP), the age of diagnosis, the mode of onset, the type of pancreatic abdominal pain, pancreatic calculi, abnormal blood glucose (impaired fasting glucose, diabetes mellitus), steatorrhea, pseudocyst, common bile duct stricture, pancreatogenic portal hypertension, severe acute pancreatitis (SAP) and the occurrence of other events, etc.（Only occurrences were recorded as occurring or not occurring）
|
Day 1
|
|
Relevant treatment information for chronic pancreatitis (CP)
Time Frame: Day 1
|
Previous treatment methods, the status of pancreatic duct decompression, the morphology of the main pancreatic duct, the in-place condition of the stent after endoscopic surgery, etc.（Only occurrences were recorded as occurring or not occurring）
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Liang-hao Hu, MD, 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
- Thierens N, Verdonk RC, Lohr JM, van Santvoort HC, Bouwense SA, van Hooft JE. Chronic pancreatitis. Lancet. 2025 Dec 21;404(10471):2605-2618. doi: 10.1016/S0140-6736(24)02187-1. Epub 2024 Dec 5.
- Hao L, Wang T, He L, Bi YW, Zhang D, Zeng XP, Xin L, Pan J, Wang D, Ji JT, Du TT, Lin JH, Wang LS, Zou WB, Chen H, Xie T, Guo HL, Li BR, Liao Z, Xu ZL, Li ZS, Hu LH. Risk factor for steatorrhea in pediatric chronic pancreatitis patients. BMC Gastroenterol. 2018 Dec 5;18(1):182. doi: 10.1186/s12876-018-0902-z.
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)
June 1, 2022
Primary Completion (Actual)
September 30, 2024
Study Completion (Actual)
October 10, 2024
Study Registration Dates
First Submitted
April 7, 2025
First Submitted That Met QC Criteria
April 23, 2025
First Posted (Actual)
April 27, 2025
Study Record Updates
Last Update Posted (Actual)
April 27, 2025
Last Update Submitted That Met QC Criteria
April 23, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP-ESRF
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
product manufactured in and exported from the U.S.
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.