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

NCT06946108 | Completed DMC

• 1 other identifier: CP-ESRF
• Study Type: observational
• Target: 1,101
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pancreatitis; Pancreatic Exocrine Insufficiency

Keywords

chronic pancreatitis; Pancreatic Exocrine Insufficiency

Outcome Measures

Primary Outcomes (1)

• Detection of Pancreatic Exocrine Function in CP Patients

  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.

  Day 1

Secondary Outcomes (3)

• The demographic information of the patients

  Day 1

• The information of the patients' natural disease course

  Day 1

• Relevant treatment information for chronic pancreatitis (CP)

  Day 1

Study Arms (1)

the patients diagnosed with chronic pancreatitis who underwent inpatient care

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,Voluntary retention of fecal samples for FE-1 detection in CP patients

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

Interventions

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.

the patients diagnosed with chronic pancreatitis who underwent inpatient care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (2)

• 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.

  PMID: 39647500 BACKGROUND

• 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.

  PMID: 30518343 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

feces, for the detection of FE-1

MeSH Terms

Conditions

Pancreatitis, Chronic; Exocrine Pancreatic Insufficiency

Condition Hierarchy (Ancestors)

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

Study Officials

• Liang-hao Hu, MD

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 27, 2025
• Study Start: June 1, 2022
• Primary Completion: September 30, 2024
• Study Completion: October 10, 2024
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)