Skip to main content
OpenTrials
Completed

NCT Number: NCT06946108

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Detection of Pancreatic Exocrine Function in Patients with Chronic Pancreatitis (CP)

Diagnostic Test

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.

Primary outcomes

  1. Detection of Pancreatic Exocrine Function in CP Patients

    Time frame: Day 1

    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.

Secondary outcomes

  1. The demographic information of the patients

    Time frame: Day 1

    The 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）

  2. The information of the patients' natural disease course

    Time frame: Day 1

    The 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）

  3. Relevant treatment information for chronic pancreatitis (CP)

    Time frame: Day 1

    Previous 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）

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

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

Acronym: CP-ESRF

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 27, 2025
Registry last updated
Apr 27, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.