PE-1 in the Diagnosis of Pancreatic Exocrine Insufficiency

NCT05791110 | Completed

• 1 other identifier: PE1-PEI
• Study Type: interventional
• Target: 1,053
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to evaluate and determine the clinical performance of Fecal Pancreatic Elastase 1 Test in the diagnosis of pancreatic exocrine insufficiency.

Conditions

Pancreatic Exocrine Insufficiency

Keywords

PE-1; Pancreatic exocrine insufficiency

Outcome Measures

Primary Outcomes (1)

• Reliability of fecal pancreatic elastase 1 test in the diagnosis of PEI

  Diagnostic consistency (kappa value) of fecal pancreatic elastase 1 test

  1 week

Secondary Outcomes (3)

• Accuracy of fecal pancreatic elastase 1 test in the diagnosis of PEI

  1 week

• Predictive value of fecal pancreatic elastase 1 test in the diagnosis of PEI

  1 week

• Accuracy, reliability, and predictive of fecal pancreatic elastase 1 test in the diagnosis of severe PEI

  1 week

Study Arms (1)

Pancreatic exocrine function

OTHER

Strict clinical diagnosis and fecal pancreatic elastase 1 test were performed for each subject (including PEI patients (n=525) and non-PEI patients (n=528))

Diagnostic Test: Fecal pancreatic elastase 1 test

Interventions

Fecal pancreatic elastase 1 test DIAGNOSTIC_TEST

Fecal pancreatic elastase 1 test are immunoassays for the quantitative determination of fecal pancreatic elastase in human stool samples.

Pancreatic exocrine function

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 【patients with clinical diagnosed PEI】
• Inpatients or outpatients of both sexes, aged 18 to 80 years.
• Patients with pancreatic disease or after pancreatic or gastric resection (one of the following)
• Chronic pancreatitis.
• At least 3 months after pancreatectomy (surgical procedures included total pancreatectomy, pancreaticoduodenectomy, pylorus-preserving pancreaticoduodenectomy, and distal pancreatectomy).
• Patients recovering from severe acute pancreatitis (duration less than 24 months).
• More than 3 months after gastrectomy (surgical methods included total gastrectomy, proximal gastrectomy, and distal gastrectomy).
• Enrolled patients had at least one of the following symptoms (except those after pancreatectomy)
• abdominal distension.
• Weight loss (weight loss is defined as loss of more than 5% of basal body weight in one year).
• steatorrhea.
• Agreed to participate in the study and signed an informed consent form.
• 【patients without clinical diagnosed PEI】
• Both male and female, aged between 18 and 80 years old.
• Patients who met one of the following criteria were included in the study:

You may not qualify if:

• Pregnant women
• Critically ill patients
• The subjects with mental disorders were unable to cooperate with the researchers
• patients who had undergone ileocolon bladder replacement surgery or complicated with intestinal obstruction and other diseases that could not collect feces
• the quantity of fecal samples, storage and transportation conditions of samples do not meet the requirements of the kit
• patients who underwent two or more times of gastrectomy or pancreatectomy

Sponsors & Collaborators

• Changhai Hospital: lead
• Xuanwu Hospital, Beijing: collaborator
• Peking Union Medical College Hospital: collaborator

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• zhuan liao

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: March 30, 2023
• Study Start: July 30, 2020
• Primary Completion: May 30, 2021
• Study Completion: August 26, 2021
• Last Updated: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)