Chronic PancreatitisNCT06925204
Natural Course and Therapeutic Effect of Chronic Pancreatitis
An observational study of Chronic Pancreatitis, run by Changhai Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Pancreatitis
- What is being tested?
- Observation
- Type of treatment
- Pill or oral medicine
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 13 Apr 2025to 31 Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Chronic pancreatitis patients in China.
Who may be able to join
- Patients diagnosed with chronic pancreatitis.
Who cannot join
- Patients who refuse to sign informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality
Lianghao Hu, M.D., +86-13817593520, lianghao-hu@smmu.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pancreatitis
- Being tested
- Observation
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| chronic pancreatitis | This group included all enrolled patients with CP. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complications
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.
Measured: Annually for 10 years post-enrollment (Year 1 through Year 10)
Secondary outcomes (6)
Incidence of pancreatic cancer
The incidence of pancreatic cancer after the diagnosis of chronic pancreatitis
Measured: 5 and 10 years after enrollment
Efficacy of endoscopic treatment
Proportion of patients with chronic pancreatitis who had pain relief after conservative, endoscopic (ESWL and ERCP), or surgical treatment
Measured: 1 year after treatment
Scores of quality of life
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.
Measured: Annually for 10 years post-enrollment (Year 1 through Year 10)
HbA1c level
Glycated hemoglobin (HbA1c) level measured in venous blood (unit: %).
Measured: Baseline and Year 1 to Year 10 post-enrollment (annually)
Blood glucose profile characteristics
Blood glucose profile from mixed-meal glucose tolerance test (MMTT) and continuous glucose monitoring system (CGMS) (unit: mmol/L or mg/dL).
Measured: Baseline and Year 1 to Year 10 post-enrollment (annually)
Pancreatic and gut hormone levels
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).
Measured: Baseline and Year 1 to Year 10 post-enrollment (annually)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start13 Apr 2025
- Primary completion1 Dec 2035 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Changzheng Hospital
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Zhaoshen Li, M.D., Study chair, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925204
- Sponsor's protocol ID
- CCPC
- Status last verified
- Apr 2025
- First submitted
- 20 Mar 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kichler A, Jang S. Chronic Pancreatitis: Epidemiology, Diagnosis, and Management Updates. Drugs. 2020 Aug;80(12):1155-1168. doi: 10.1007/s40265-020-01360-6.
PubMed 32647920Oh TK, Song IA. Five-year mortality trends associated with chronic pancreatitis in South Korea: A population based cohort study. Pancreatology. 2020 Jul;20(5):828-833. doi: 10.1016/j.pan.2020.04.024. Epub 2020 Jun 18.
PubMed 32646739Sellers ZM, MacIsaac D, Yu H, Dehghan M, Zhang KY, Bensen R, Wong JJ, Kin C, Park KT. Nationwide Trends in Acute and Chronic Pancreatitis Among Privately Insured Children and Non-Elderly Adults in the United States, 2007-2014. Gastroenterology. 2018 Aug;155(2):469-478.e1. doi: 10.1053/j.gastro.2018.04.013. Epub 2018 Apr 13.
PubMed 29660323Wang LW, Li ZS, Li SD, Jin ZD, Zou DW, Chen F. Prevalence and clinical features of chronic pancreatitis in China: a retrospective multicenter analysis over 10 years. Pancreas. 2009 Apr;38(3):248-54. doi: 10.1097/MPA.0b013e31818f6ac1.
PubMed 19034057
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Course and Therapeutic Effect of Chronic Pancreatitis: a Prospect Cohort Study
- ClinicalTrials.gov ID
- NCT06925204
- Acronym / sponsor ID
- CCPC
- Conditions
- Chronic Pancreatitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Shanghai Changzheng Hospital
- Study start
- 13 Apr 2025 (actual)
- Primary completion
- 1 Dec 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 13 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic pancreatitis | – | Other: ObservationThis group included all enrolled patients with CP. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chronic pancreatitis patients in China.
Key inclusion criteria (1 listed)
- Patients diagnosed with chronic pancreatitis.
Key exclusion criteria (1 listed)
- Patients who refuse to sign informed consent.
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 |
|---|---|---|
| ObservationBased 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. | Other | chronic pancreatitis |
Primary outcome
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.
6 secondary outcomes
Incidence of pancreatic cancer
Time frame: 5 and 10 years after enrollment
Efficacy of endoscopic treatment
Time frame: 1 year after treatment
Scores of quality of life
Time frame: 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)
Blood glucose profile characteristics
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Results publication: PubMed 32647920Kichler A, Jang S. Chronic Pancreatitis: Epidemiology, Diagnosis, and Management Updates. Drugs. 2020 Aug;80(12):1155-1168. doi: 10.1007/s40265-020-01360-6.
- Results publication: PubMed 32646739Oh TK, Song IA. Five-year mortality trends associated with chronic pancreatitis in South Korea: A population based cohort study. Pancreatology. 2020 Jul;20(5):828-833. doi: 10.1016/j.pan.2020.04.024. Epub 2020 Jun 18.
- Results publication: PubMed 29660323Sellers ZM, MacIsaac D, Yu H, Dehghan M, Zhang KY, Bensen R, Wong JJ, Kin C, Park KT. Nationwide Trends in Acute and Chronic Pancreatitis Among Privately Insured Children and Non-Elderly Adults in the United States, 2007-2014. Gastroenterology. 2018 Aug;155(2):469-478.e1. doi: 10.1053/j.gastro.2018.04.013. Epub 2018 Apr 13.
- Results publication: PubMed 19034057Wang LW, Li ZS, Li SD, Jin ZD, Zou DW, Chen F. Prevalence and clinical features of chronic pancreatitis in China: a retrospective multicenter analysis over 10 years. Pancreas. 2009 Apr;38(3):248-54. doi: 10.1097/MPA.0b013e31818f6ac1.
- 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.
Zhaoshen Li, M.D. study chair
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, 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 15 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lianghao Hu, M.D. (+86-13817593520, lianghao-hu@smmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of complications (time frame: Annually for 10 years post-enrollment (Year 1 through Year 10)). 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 NCT06925204, which also lists 4 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 15 Apr 2025.