Chronic PancreatitisNCT05352932
Establishment of Clinical Staging of Chronic Pancreatitis Based on Histopathology of Pancreatic Duct Biopsy
An observational study of Chronic Pancreatitis, run by Changhai Hospital at 1 site in China.
Trial summary
This study intends to establish the clinical staging of chronic pancreatitis based on histopathology through pancreatic duct biopsy technology. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Pancreatitis
- What is being tested?
- pancreatic duct biopsy
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2022to Dec 2022
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatients meeting the eligibility criteria.
Who may be able to join
- Patients with chronic pancreatitis or idiopathic recurrent acute pancreatitis;
- In line with the indications for ERCP treatment.
Who cannot join
- suspected to have malignant tumors;
- history of pancreatic surgery or gastrojejunostomy (Billroth II);
- bile duct stricture secondary to cholangitis or chronic pancreatitis;
- acute pancreatitis exacerbation or acute exacerbation of chronic pancreatitis;
- coagulation dysfunction (INR≥1.5 or platelet count≤50×10^9/L);
- pregnant or breastfeeding women;
- patients who refused to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Establishment of Clinical Staging of Chronic Pancreatitis Based on Histopathology of Pancreatic Duct Biopsy: a Cross-sectional Clinical Study
This study intends to establish the clinical staging of chronic pancreatitis based on histopathology through pancreatic duct biopsy technology.
Read the detailed description
Chronic pancreatitis (CP) is an inflammatory disease that can causes progressive fibrosis of pancreatic tissue and eventually leads to damage of pancreatic exocrine and endocrine. According to statistics, the prevalence of CP in China is 13/10 million, which is still increasing. Pancreatic duct stones are the most important pathological changes of CP. More than 50% of patients with CP are accompanied by pancreatic duct stones, which can lead to pancreatic duct obstruction, hypertension and tissue ischemia. Removal of pancreatic duct stones under Endoscopic retrograde cholangiopancreatography (ERCP) are the first choice.
Pathological features of CP include pancreatic parenchymal atrophy and interstitial fibrosis resulting from chronic inflammatory damage. Although there are numerous criteria for clinical staging and severity grading of CP, they all have their own limitations, and none of them have been validated by randomized controlled trials. There is also no clear definition of the clinical stage and severity of CP in the guidelines for the diagnosis and treatment of CP. According to the "Clinical Guideline: Chronic Pancreatitis" issued by the American College of Gastroenterology in 2020, histopathology is the "gold standard" for the diagnosis of CP.
In the past ten years, the technology of mother-daughter scope has developed rapidly. The duodenoscope is used as the mother scope, and the cholangiopancreatoscope is used as the daughter scope. The optical fiber or digital imaging system carried by the daughter scope can directly observe the internal situation of the pancreatic and bile ducts. The channel allows the endoscopist to precisely biopsy the wall of the main pancreatic duct with a biopsy forceps. This technology improves the predicament of pancreatic tissue biopsy in the past, allowing ERCP treatment in patients with CP and pancreatic tissue biopsy to be carried out simultaneously.
- Conditions
- Chronic Pancreatitis
- Being tested
- pancreatic duct biopsy
- Keywords
- Endoscopic Retrograde Cholangiopancreatography, Histology
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pancreatic duct biopsyDiagnostic test
Enrolled patients will undergo a baseline assessment, including CP history, clinical symptoms, imaging tests, laboratory tests, etc.
Then, according to the clinical standard of diagnosis and treatment of chronic pancreatitis, ERCP (with or without Extracorporeal Shock Wave Lithotripsy (ESWL) / endoscopic lithotripsy) will be performed for patients with calculi; pancreatic stent or nasopancreatic stent will be placed for patients with pancreatic duct stenosis. During ERCP, the patient's pancreatic tissue will be biopsied and sent for pathological examination.
| Study group | Role | What they receive |
|---|---|---|
| patient group | Patients with chronic pancreatitis or idiopathic recurrent acute pancreatitis are considered as study subjects. Receives: Diagnostic Test: pancreatic duct biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histopathological scoring of pancreatic duct biopsy specimens
Histopathological evaluations of pancreatic duct biopsies include the presence of ductal squamous metaplasia, the presence of ductal intestinal metaplasia, the presence of ductal dysplasia, the presence of acinar parenchyma, the presence of lobular ducts, the degree of inflammatory cell infiltration (lymphocytes, plasma cells and mast cells) ) and the degree of interstitial fibrosis.
Measured: 14 days after ERCP procedure
Secondary outcomes (1)
post-ERCP complications
Major post-ERCP complications includes post-ERCP pancreatitis, bleeding, infection, and perforation, which are classified as mild, moderate, or severe, depending mainly on the length of hospitalization and the need for invasive treatment.
Measured: 30 days after ERCP procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start9 Mar 2022
- Primary completion10 Mar 2022
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PancreatitisStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Liang-hao Hu, MD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352932
- Sponsor's protocol ID
- ECHO20220321
- Status last verified
- Sep 2022
- First submitted
- 24 Apr 2022
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hao L, Liu Y, Xie T, Wang T, Guo HL, Pan J, Wang D, Bi YW, Ji JT, Xin L, Du TT, Lin JH, Zhang D, Zeng XP, Zou WB, Chen H, Li BR, Liao Z, Cong ZJ, Shi RH, Li ZS, Hu LH. Risk Factors and Nomogram for Pancreatic Stone Formation in Chronic Pancreatitis over a Long-Term Course: A Cohort of 2,153 Patients. Digestion. 2020;101(4):473-483. doi: 10.1159/000500941. Epub 2019 Jun 25.
PubMed 31238312
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Clinical Staging of Chronic Pancreatitis Based on Histopathology of Pancreatic Duct Biopsy: a Cross-sectional Clinical Study
- ClinicalTrials.gov ID
- NCT05352932
- Acronym / sponsor ID
- ECHO20220321
- Conditions
- Chronic Pancreatitis
- Keywords
- Endoscopic Retrograde Cholangiopancreatography, Histology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- Dec 2022 (estimated)
- First posted
- 29 Apr 2022 (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.
This study intends to establish the clinical staging of chronic pancreatitis based on histopathology through pancreatic duct biopsy technology.
Detailed description
Chronic pancreatitis (CP) is an inflammatory disease that can causes progressive fibrosis of pancreatic tissue and eventually leads to damage of pancreatic exocrine and endocrine. According to statistics, the prevalence of CP in China is 13/10 million, which is still increasing. Pancreatic duct stones are the most important pathological changes of CP. More than 50% of patients with CP are accompanied by pancreatic duct stones, which can lead to pancreatic duct obstruction, hypertension and tissue ischemia. Removal of pancreatic duct stones under Endoscopic retrograde cholangiopancreatography (ERCP) are the first choice.
Pathological features of CP include pancreatic parenchymal atrophy and interstitial fibrosis resulting from chronic inflammatory damage. Although there are numerous criteria for clinical staging and severity grading of CP, they all have their own limitations, and none of them have been validated by randomized controlled trials. There is also no clear definition of the clinical stage and severity of CP in the guidelines for the diagnosis and treatment of CP. According to the "Clinical Guideline: Chronic Pancreatitis" issued by the American College of Gastroenterology in 2020, histopathology is the "gold standard" for the diagnosis of CP.
In the past ten years, the technology of mother-daughter scope has developed rapidly. The duodenoscope is used as the mother scope, and the cholangiopancreatoscope is used as the daughter scope. The optical fiber or digital imaging system carried by the daughter scope can directly observe the internal situation of the pancreatic and bile ducts. The channel allows the endoscopist to precisely biopsy the wall of the main pancreatic duct with a biopsy forceps. This technology improves the predicament of pancreatic tissue biopsy in the past, allowing ERCP treatment in patients with CP and pancreatic tissue biopsy to be carried out simultaneously.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient group | – | Diagnostic Test: pancreatic duct biopsyPatients with chronic pancreatitis or idiopathic recurrent acute pancreatitis are considered as study subjects. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients meeting the eligibility criteria.
Key inclusion criteria (2 listed)
- Patients with chronic pancreatitis or idiopathic recurrent acute pancreatitis;
- In line with the indications for ERCP treatment.
Key exclusion criteria (7 listed)
- suspected to have malignant tumors;
- history of pancreatic surgery or gastrojejunostomy (Billroth II);
- bile duct stricture secondary to cholangitis or chronic pancreatitis;
- acute pancreatitis exacerbation or acute exacerbation of chronic pancreatitis;
- coagulation dysfunction (INR≥1.5 or platelet count≤50×10^9/L);
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 |
|---|---|---|
| pancreatic duct biopsyEnrolled patients will undergo a baseline assessment, including CP history, clinical symptoms, imaging tests, laboratory tests, etc. Then, according to the clinical standard of diagnosis and treatment of chronic pancreatitis, ERCP (with or without Extracorporeal Shock Wave Lithotripsy (ESWL) / endoscopic lithotripsy) will be performed for patients with calculi; pancreatic stent or nasopancreatic stent will be placed for patients with pancreatic duct stenosis. During ERCP, the patient's pancreatic tissue will be biopsied and sent for pathological examination. | Diagnostic test | patient group |
Primary outcome
Histopathological scoring of pancreatic duct biopsy specimens
Time frame: 14 days after ERCP procedure
Histopathological evaluations of pancreatic duct biopsies include the presence of ductal squamous metaplasia, the presence of ductal intestinal metaplasia, the presence of ductal dysplasia, the presence of acinar parenchyma, the presence of lobular ducts, the degree of inflammatory cell infiltration (lymphocytes, plasma cells and mast cells) ) and the degree of interstitial fibrosis.
1 secondary outcome
post-ERCP complications
Time frame: 30 days after ERCP procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Background: PubMed 31238312Hao L, Liu Y, Xie T, Wang T, Guo HL, Pan J, Wang D, Bi YW, Ji JT, Xin L, Du TT, Lin JH, Zhang D, Zeng XP, Zou WB, Chen H, Li BR, Liao Z, Cong ZJ, Shi RH, Li ZS, Hu LH. Risk Factors and Nomogram for Pancreatic Stone Formation in Chronic Pancreatitis over a Long-Term Course: A Cohort of 2,153 Patients. Digestion. 2020;101(4):473-483. doi: 10.1159/000500941. Epub 2019 Jun 25.
- 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.
Liang-hao Hu, MD 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?
An observational study of Chronic Pancreatitis, 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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 14 Sep 2022. 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?
Results are not available in the source record.
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?
Histopathological scoring of pancreatic duct biopsy specimens (time frame: 14 days after ERCP procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05352932, which also lists 1 linked publication.
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 14 Sep 2022; AzTrials last refreshed its copy on 8 Nov 2026.