Skip to content

Investigation on the Current Situation and Risk Factors Analysis of Exocrine Insufficiency in Chronic Pancreatitis

Investigation on the Current Situation and Risk Factors Analysis of Exocrine Insufficiency in Chronic Pancreatitis: A Prospective Cohort Investigation Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06946108
Acronym
CP-ESRF
Enrollment
1101
Registered
2025-04-27
Start date
2022-06-01
Completion date
2024-10-10
Last updated
2025-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pancreatitis, Pancreatic Exocrine Insufficiency

Keywords

chronic pancreatitis, Pancreatic Exocrine Insufficiency

Brief 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, 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.

Interventions

DIAGNOSTIC_TESTDetection 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.

Sponsors

Changhai Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. patients who underwent inpatient care at Shanghai Changhai Hospital (a WHO Collaborating Center for Pancreatology) between June 2022 and September 2024. 2. patients diagnosed with chronic pancreatitis (CP) 3. Voluntarily preserve feces for the detection of fecal elastase-1 (FE-1)

Exclusion criteria

1. Patients who were diagnosed with pancreatic cancer within 2 years after being diagnosed with chronic pancreatitis (CP) 2. patients with groove pancreatitis, 3. patients with autoimmune pancreatitis.

Design outcomes

Primary

MeasureTime frameDescription
Detection of Pancreatic Exocrine Function in CP PatientsDay 1For 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.

Secondary

MeasureTime frameDescription
The demographic information of the patientsDay 1The 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)
The information of the patients' natural disease courseDay 1The 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)
Relevant treatment information for chronic pancreatitis (CP)Day 1Previous 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)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026