Natural Course and Therapeutic Effect of Chronic Pancreatitis

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: Recruiting
• Conditions: Chronic Pancreatitis
• Intervention / Treatment: Other: Observation

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: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Lianghao Hu, M.D.; Phone Number: +86-13817593520; Email: lianghao-hu@smmu.edu.cn
• Study Contact Backup: Name: Dan Wang, M.D.; Phone Number: +86 13817115618; Email: jsjdwangdan08@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Changhai Hospital
      • Contact: Lianghao Hu, M.D.; Phone Number: +86-13817593520; Email: lianghao-hu@smmu.edu.cn

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
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.	Annually for 10 years post-enrollment (Year 1 through Year 10)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of pancreatic cancer	The incidence of pancreatic cancer after the diagnosis of chronic pancreatitis	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	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.	Annually for 10 years post-enrollment (Year 1 through Year 10)
HbA1c level	Glycated hemoglobin (HbA1c) level measured in venous blood (unit: %).	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).	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).	Baseline and Year 1 to Year 10 post-enrollment (annually)

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Collaborators: Shanghai Changzheng Hospital
• Investigators: Study Chair: Zhaoshen Li, M.D., Changhai Hospital

Publications and helpful links

General 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.
• Oh 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.
• Sellers 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.
• Wang 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2025
• Primary Completion (Estimated): December 1, 2035
• Study Completion (Estimated): December 31, 2035

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: April 6, 2025
• First Posted (Actual): April 13, 2025

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 12, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Pancreatitis, Chronic
• Other Study ID 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