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NCT Number: NCT06925204

Natural Course and Therapeutic Effect of Chronic Pancreatitis

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.

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Key information

Conditions

Chronic Pancreatitis Chronic Disease Digestive System Diseases Disease Attributes Pancreatic Diseases Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with chronic pancreatitis.

Exclusion criteria

  • Patients who refuse to sign informed consent.

Treatment and study plan

observation

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Incidence of pancreatic cancer

    Time frame: 5 and 10 years after enrollment

    The incidence of pancreatic cancer after the diagnosis of chronic pancreatitis

  2. Efficacy of endoscopic treatment

    Time frame: 1 year after treatment

    Proportion of patients with chronic pancreatitis who had pain relief after conservative, endoscopic (ESWL and ERCP), or surgical treatment

  3. Scores of quality of life

    Time frame: Annually for 10 years post-enrollment (Year 1 through Year 10)

    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.

  4. HbA1c level

    Time frame: Baseline and Year 1 to Year 10 post-enrollment (annually)

    Glycated hemoglobin (HbA1c) level measured in venous blood (unit: %).

  5. Blood glucose profile characteristics

    Time frame: Baseline and Year 1 to Year 10 post-enrollment (annually)

    Blood glucose profile from mixed-meal glucose tolerance test (MMTT) and continuous glucose monitoring system (CGMS) (unit: mmol/L or mg/dL).

  6. Pancreatic and gut hormone levels

    Time frame: Baseline and Year 1 to Year 10 post-enrollment (annually)

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Dan Wang, M.D.

CONTACT

[email protected]

+86 13817115618

Lianghao Hu, M.D.

CONTACT

[email protected]

+86-13817593520

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Collaborators

  • Shanghai Changzheng Hospital

Registry information

Official study title

Natural Course and Therapeutic Effect of Chronic Pancreatitis: a Prospect Cohort Study

Important dates

Study start
2025
Primary completion
2035
Study completion
2035
First posted
Apr 13, 2025
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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