Testing pancreatic function in patients with chronic pancreatitis and diabetes

Establishment and Clinical Application of Pancreatic Endocrine and Exocrine Function Tests

This study is trying to see how well the pancreas works in people with chronic pancreatitis and diabetes to improve diagnosis and treatment.

Quick facts

• Study type: Observational
• Enrollment: 2400 (estimated)
• Sex: All
• Sponsor: Changhai Hospital (other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT06006312 on ClinicalTrials.gov

What this trial studies

This observational study aims to enhance the understanding of pancreatic exocrine insufficiency (PEI) in China by collecting epidemiological data and determining the fecal elastase-1 (FE-1) cut-off value for classifying PEI severity. It will involve recording baseline data and conducting the FE-1 test in elderly and community populations, as well as in chronic pancreatitis patients. The study also seeks to explore the clinical differences between type 3c diabetes mellitus and type 2 diabetes mellitus. By utilizing non-invasive tests, the study hopes to improve diagnostic accuracy and patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include elderly individuals over 60 years old from the community and adults aged 18 to 80 diagnosed with chronic pancreatitis.

Not a fit: Patients in critical condition or those with mental disorders that prevent cooperation will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better diagnosis and management of pancreatic exocrine insufficiency and related conditions, improving patient care.

How similar studies have performed: While similar studies have explored pancreatic function testing, this study's specific focus on the Chinese population and the classification of PEI is relatively novel.

Eligibility criteria

For elderly population and community population:

Inclusion Criteria:

1. Agree to participate in the study and sign the informed consent.
2. Age of elderly participants are over 60 years old and the participants from community is unlimited.

Exclusion Criteria:

1. Participants in critical condition.
2. Have mental disorders and unable cooperate with investigators.
3. Have received bladder replacement with ileocolon surgery, or have intestinal obstruction and other diseases that can not defecate.

For chronic pancreatitis patients:

Inclusion Criteria:

1. Patients with chronic pancreatitis.
2. Age between 18 and 80 years.

Exclusion Criteria:

1. Pregnant or breastfeeding women
2. Participants in critical condition.
3. Have mental disorders and unable cooperate with investigators.
4. Have received bladder replacement with ileocolon surgery, or have intestinal obstruction and other diseases that can not defecate.
5. Fecal sample quality, storage and transportation do not meet the requirements of fecal elastase-1 test.
6. Have undergone gastrectomy or pancreatectomy more than once.

For chronic pancreatitis patients with diabetes and patients with type 2 diabetes mellitus:

Inclusion Criteria (meet 1 or 2):

1. Patients with chronic pancreatitis and diabetes mellitus.
2. Patients with type 2 diabetes mellitus.

Exclusion Criteria:

1. Patients with type 2 diabetes mellitus.
2. Participants in critical condition.
3. Have mental disorders and unable cooperate with investigators.

Where this trial is running

Shanghai

• Changhai Hospital — Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Liang-hao Hu, MD

Conditions: Chronic Pancreatitis, Pancreatic Exocrine Insufficiency, Diabetes Mellitus, Community Populations, Fecal Elastase-1 Test