Chronic PancreatitisCP-ESRFNCT06946108
Investigation on the Current Situation and Risk Factors Analysis of Exocrine Insufficiency in Chronic Pancreatitis
An observational study of Chronic Pancreatitis and Pancreatic Exocrine Insufficiency, run by Changhai Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Pancreatitis, Pancreatic Exocrine Insufficiency
- What is being tested?
- Detection of Pancreatic Exocrine Function in Patients with Chronic Pancreatitis (CP)
- How many people
- 1,101 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 10 Oct 2024
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Detection of Pancreatic Exocrine Function in Patients with Chronic Pancreatitis (CP)
- Keywords
- chronic pancreatitis, Pancreatic Exocrine Insufficiency
- Medical subject headings
- Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of Pancreatic Exocrine Function in Patients with Chronic Pancreatitis (CP)Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Detection of Pancreatic Exocrine Function in Patients with Chronic Pancreatitis (CP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Pancreatic Exocrine Function 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.
Measured: Day 1
Secondary outcomes (3)
The demographic information of the patients
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）
Measured: Day 1
The information of the patients' natural disease course
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）
Measured: Day 1
Relevant treatment information for chronic pancreatitis (CP)
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）
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start1 Jun 2022
- Primary completion30 Sep 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,101 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Liang-hao Hu, MD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946108
- Sponsor's protocol ID
- CP-ESRF
- Acronym
- CP-ESRF
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 39647500Hao 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.
PubMed 30518343
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on the Current Situation and Risk Factors Analysis of Exocrine Insufficiency in Chronic Pancreatitis: A Prospective Cohort Investigation Study
- ClinicalTrials.gov ID
- NCT06946108
- Acronym / sponsor ID
- CP-ESRF / CP-ESRF
- Keywords
- chronic pancreatitis, Pancreatic Exocrine Insufficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,101 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the patients diagnosed with chronic pancreatitis who underwent inpatient care | – | Diagnostic Test: Detection of Pancreatic Exocrine Function in Patients with Chronic Pancreatitis (CP)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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Detection of Pancreatic Exocrine Function in Patients with Chronic Pancreatitis (CP)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. | Diagnostic test | the patients diagnosed with chronic pancreatitis who underwent inpatient care |
Primary outcome
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.
3 secondary outcomes
The demographic information of the patients
Time frame: Day 1
The information of the patients' natural disease course
Time frame: Day 1
Relevant treatment information for chronic pancreatitis (CP)
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Results publication: PubMed 39647500Thierens 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.
- Results publication: PubMed 30518343Hao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liang-hao Hu, MD principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pancreatitis and Pancreatic Exocrine Insufficiency, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of Pancreatic Exocrine Function in CP Patients (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06946108, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.