Pancreatic Exocrine InsufficiencyNCT05791110
PE-1 in the Diagnosis of Pancreatic Exocrine Insufficiency
A study testing Fecal pancreatic elastase 1 test in people with Pancreatic Exocrine Insufficiency, run by Changhai Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Exocrine Insufficiency
- What is being tested?
- Fecal pancreatic elastase 1 test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,053 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2020to 26 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 【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).
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- 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:
- Patients with functional gastrointestinal diseases who had no history of pancreatectomy, gastrectomy, or abdominal radiotherapy were included.
- Healthy volunteers.
- Patients with benign hepatobiliary diseases, thyroid, breast diseases, and digestive tract diseases who had no history of pancreatectomy, gastrectomy, or abdominal radiotherapy were included.
- Agreed to participate in the study and signed an informed consent form.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Value of Fecal Pancreatic Elastase 1 in the Diagnosis of Pancreatic Exocrine Insufficiency: a Multi-center Study
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.
Read the detailed description
Fecal Pancreatic Elastase 1 (PE-1)Test has high diagnostic accuracy in pancreatic exocrine insufficiency (PEI), has become a painless noninvasive diagnostic modality in clinical practice, and has been widely used in clinical practice.
However, in China, the diagnostic ability of the PE-1 test in the Chinese population has not been demonstrated and has not been reported. Meanwhile, pancreatin stimulation, 13C-mixed triglyceride breath test, and N-benzoyl-L-tyrosyl-p-aminobenzoic acid test required drugs, which cannot pass the examination of the drug administration and were not allowed to be carried out to diagnose PEI in China. In addition pancreatin stimulation is an invasive test has certain risks for subjects and 72-hour fecal fat quantification was mainly used for the diagnosis of severe PEI. Therefore, This study adopted strict clinical diagnosis as a comparative method for PE-1 test to judge the ability of PE-1 test to diagnose PEI in the Chinese population.
This study aims to clarify the application efficacy of PE-1 test in PEI through a multi-center, prospective clinical study comparing PE-1 test with strict clinical diagnosis. To study the accuracy of PE-1 test in the diagnosis of PEI.
- Conditions
- Pancreatic Exocrine Insufficiency
- Being tested
- Fecal pancreatic elastase 1 test
- Keywords
- PE-1, Pancreatic exocrine insufficiency
- Medical subject headings
- Exocrine Pancreatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal pancreatic elastase 1 testDiagnostic test
Fecal pancreatic elastase 1 test are immunoassays for the quantitative determination of fecal pancreatic elastase in human stool samples.
| Study group | Role | What they receive |
|---|---|---|
| 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)) Receives: Diagnostic Test: Fecal pancreatic elastase 1 test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of fecal pancreatic elastase 1 test in the diagnosis of PEI
Diagnostic consistency (kappa value) of fecal pancreatic elastase 1 test
Measured: 1 week
Secondary outcomes (3)
Accuracy of fecal pancreatic elastase 1 test in the diagnosis of PEI
Diagnostic sensitivity, specificity, positive likelihood ratio, negative likelihood ratio of fecal pancreatic elastase 1 test
Measured: 1 week
Predictive value of fecal pancreatic elastase 1 test in the diagnosis of PEI
Positive predictive value, negative predictive value of fecal pancreatic elastase 1 test
Measured: 1 week
Accuracy, reliability, and predictive of fecal pancreatic elastase 1 test in the diagnosis of severe PEI
Severe PEI was defined as PE-1 content in feces less than 100μg/g. Diagnostic consistency (kappa value), sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, positive predictive value, negative predictive value of fecal pancreatic elastase 1 test in severe PEI.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start30 Jul 2020
- Primary completion30 May 2021
- Study completion26 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Exocrine InsufficiencyStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,053 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuan Liao, Changhai Hospital
- Investigators
- zhuan liao, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791110
- Sponsor's protocol ID
- PE1-PEI
- Status last verified
- Apr 2023
- First submitted
- 17 Mar 2023
- Last updated
- 13 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Fecal Pancreatic Elastase 1 in the Diagnosis of Pancreatic Exocrine Insufficiency: a Multi-center Study
- ClinicalTrials.gov ID
- NCT05791110
- Acronym / sponsor ID
- PE1-PEI
- Conditions
- Pancreatic Exocrine Insufficiency
- Keywords
- PE-1, Pancreatic exocrine insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,053 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing, Peking Union Medical College Hospital
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 26 Aug 2021 (actual)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Fecal Pancreatic Elastase 1 (PE-1)Test has high diagnostic accuracy in pancreatic exocrine insufficiency (PEI), has become a painless noninvasive diagnostic modality in clinical practice, and has been widely used in clinical practice.
However, in China, the diagnostic ability of the PE-1 test in the Chinese population has not been demonstrated and has not been reported. Meanwhile, pancreatin stimulation, 13C-mixed triglyceride breath test, and N-benzoyl-L-tyrosyl-p-aminobenzoic acid test required drugs, which cannot pass the examination of the drug administration and were not allowed to be carried out to diagnose PEI in China. In addition pancreatin stimulation is an invasive test has certain risks for subjects and 72-hour fecal fat quantification was mainly used for the diagnosis of severe PEI. Therefore, This study adopted strict clinical diagnosis as a comparative method for PE-1 test to judge the ability of PE-1 test to diagnose PEI in the Chinese population.
This study aims to clarify the application efficacy of PE-1 test in PEI through a multi-center, prospective clinical study comparing PE-1 test with strict clinical diagnosis. To study the accuracy of PE-1 test in the diagnosis of PEI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pancreatic exocrine function | Other | Diagnostic Test: Fecal pancreatic elastase 1 testStrict clinical diagnosis and fecal pancreatic elastase 1 test were performed for each subject (including PEI patients (n=525) and non-PEI patients (n=528)) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 【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)
- Enrolled patients had at least one of the following symptoms (except those after pancreatectomy)
- Agreed to participate in the study and signed an informed consent form.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal pancreatic elastase 1 testFecal pancreatic elastase 1 test are immunoassays for the quantitative determination of fecal pancreatic elastase in human stool samples. | Diagnostic test | Pancreatic exocrine function |
Primary outcome
Reliability of fecal pancreatic elastase 1 test in the diagnosis of PEI
Time frame: 1 week
Diagnostic consistency (kappa value) of fecal pancreatic elastase 1 test
3 secondary outcomes
Accuracy of fecal pancreatic elastase 1 test in the diagnosis of PEI
Time frame: 1 week
Predictive value of fecal pancreatic elastase 1 test in the diagnosis of PEI
Time frame: 1 week
Accuracy, reliability, and predictive of fecal pancreatic elastase 1 test in the diagnosis of severe PEI
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zhuan liao principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal pancreatic elastase 1 test in people with Pancreatic Exocrine Insufficiency, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability of fecal pancreatic elastase 1 test in the diagnosis of PEI (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.