Clinical trial NCT06946108: Investigation on the Current Situation and Risk Factors Analysis of Exocrine Insufficiency in Chronic Pancreatitis
Official title: Investigation on the Current Situation and Risk Factors Analysis of Exocrine Insufficiency in Chronic Pancreatitis: A Prospective Cohort Investigation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pancreatitis
Pancreatic Exocrine Insufficiency
Keywords: chronic pancreatitis
Pancreatic Exocrine Insufficiency
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 1101
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This hospital-based cohort study enrolled patients diagnosed with chronic pancreatitis (CP) who underwent inpatient care at Shanghai Changhai Hospital (a WHO Collaborating Center for Pancreatology) between June 2022 and September 2024

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Detection of Pancreatic Exocrine Function in CP Patients
timeFrame: Day 1
Secondary outcomes:
measure: The demographic information of the patients
timeFrame: Day 1
measure: The information of the patients' natural disease course
timeFrame: Day 1
measure: Relevant treatment information for chronic pancreatitis (CP)
timeFrame: Day 1
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital
name: Liang-hao Hu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thierens N, Verdonk RC, Lohr JM, van Santvoort HC, Bouwense SA, van Hooft JE. Chronic pancreatitis. Lancet. 2025 Dec 21;404(10471):2605-2618. doi: 10.1016/S0140-6736(24)02187-1. Epub 2024 Dec 5.
citation: Hao L, Wang T, He L, Bi YW, Zhang D, Zeng XP, Xin L, Pan J, Wang D, Ji JT, Du TT, Lin JH, Wang LS, Zou WB, Chen H, Xie T, Guo HL, Li BR, Liao Z, Xu ZL, Li ZS, Hu LH. Risk factor for steatorrhea in pediatric chronic pancreatitis patients. BMC Gastroenterol. 2018 Dec 5;18(1):182. doi: 10.1186/s12876-018-0902-z.