Chronic PancreatitisBILE-CPNCT07770412
The Biobank Integrating Longitudinal ERCP Within a Prospective Chronic Pancreatitis Cohort
An observational study of Chronic Pancreatitis, run by First People's Hospital of Hangzhou at 1 site in China.
Trial summary
The Biobank Integrating Longitudinal ERCP within a Prospective Chronic Pancreatitis Cohort (BILE-CP) is a prospective longitudinal cohort study conducted in Hangzhou, Zhejiang Province, China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pancreatitis
- What is being tested?
- This observational cohort study does not involve any interventions
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2026to 31 Aug 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients (aged 18 years and older, regardless of sex) who are clinically diagnosed with chronic pancreatitis and are receiving medical care at the study center (Hangzhou First People's Hospital) in Hangzhou, Zhejiang Province, China.
Who may be able to join
- Age ≥ 18 years, with no sex restrictions.
- Meets the diagnostic criteria for chronic pancreatitis, with a definitive diagnosis of chronic pancreatitis based on imaging, pathology, or pancreatic function tests;
- Receiving medical care at the study center and willing to accept long-term follow-up management.
- Able to cooperate with baseline data collection and scheduled follow-ups.
- Provided written informed consent.
Who cannot join
- Concomitant malignancies.
- Concurrent severe systemic diseases with an expected life expectancy of < 1 year.
- History of major pancreatic resection or pancreaticoduodenectomy.
- History of major gastrointestinal surgery.
- Pregnant or lactating population.
- Severe psychiatric disorders, cognitive dysfunction, or assessed by the investigator as having extremely poor compliance, rendering the participant unable to complete the scheduled follow-up plan.
- Other relevant conditions deemed by the investigator as potentially affecting the study results or compromising participant safety.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
First People's Hospital of Hangzhou
Hangzhou, Zhejiang, 310006
Xiaofeng Zhang, 86-0571-56005600, zhangxiaofeng@hospital.westlake.edu.cn
Zhijie Wang, PhD, 86-0571-56005600, wangzhijie0708@163.com
About this study
The Biobank Integrating Longitudinal ERCP within a Prospective Chronic Pancreatitis Cohort (BILE-CP) is a prospective longitudinal cohort study conducted in Hangzhou, Zhejiang Province, China. The study plans to consecutively enroll 1,500 patients with chronic pancreatitis for long-term follow-up (scheduled every 6 months). This cohort encompasses patients across the entire disease course of chronic pancreatitis, with a particular focus on and in-depth tracking of a sub-cohort of patients undergoing ERCP treatments. During baseline and follow-up visits, researchers will collect multidimensional data from participants, including sociodemographics, diet and lifestyle, emotional status and sleep quality, clinical phenotypes and disease characteristics, ERCP intervention details, clinical laboratory and imaging examinations, continuous glucose monitoring (CGM), and traditional Chinese medicine indicators. Concurrently, multi-site biological samples will be collected, including but not limited to blood, feces, bile, saliva, tongue coating, and urine.
Read the detailed description
Researchers will recruit participants with chronic pancreatitis, with a specific focus on the sub-population undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) interventions. This study aims to construct a prospective longitudinal database that integrates sociodemographics, lifestyle factors, emotional status and sleep quality, clinical phenotypes and disease characteristics, ERCP intervention details, laboratory and imaging examinations, traditional Chinese medicine applications, and multi-site biological samples (including blood, feces, bile, saliva, tongue coating, and urine). The primary objective is to clarify the impact of lifestyle and clinical interventions on the disease progression and stage-specific prognosis of chronic pancreatitis. Concurrently, relying on long-term patient follow-up and repeated biological sample collection, the study will systematically investigate the dynamic evolutionary patterns and underlying mechanisms of the multi-site microbiome during disease progression. By integrating patients' multidimensional information and multi-site multi-omics profiles, the research aims to explore precision management models and key biological mechanisms underlying chronic pancreatitis progression and post-ERCP prognosis. Ultimately, this study expect to provide robust scientific evidence for individualized, precise prevention and clinical decision-making in the management of chronic pancreatitis.
- Conditions
- Chronic Pancreatitis
- Being tested
- This observational cohort study does not involve any interventions
- Keywords
- chronic pancreatitis, Endoscopic Retrograde Cholangiopancreatography, multi-omics, ERCP
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This observational cohort study does not involve any interventionsOther
This observational cohort study does not involve any interventions
| Study group | Role | What they receive |
|---|---|---|
| BILE-CP Cohort: Patients with Chronic Pancreatitis Meeting Inclusion and Exclusion Criteria | All eligible patients clinically diagnosed with chronic pancreatitis and receiving standard clinical treatment at the research center. This observational cohort study excludes interventions. And the primary clinical exposure factors of interest include ERCP, lifestyle, and the use of traditional Chinese medicine and herbal remedies. Receives: Other: This observational cohort study does not involve any interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Exocrine Functions
Evaluated by scores from the pancreatic exocrine insufficiency questionnaire. The calculated final score ranges from 0 to 4. Higher scores indicate more severe symptoms and worse pancreatic exocrine function.
Measured: Six months
Incidence of Unplanned Readmissions Related to Chronic Pancreatitis and Its Complications
Evaluated by documenting the number of participants who experience at least one unplanned hospital readmission related to chronic pancreatitis and its complications within the follow-up period.
Measured: Six months
Incidence of Pancreatic Cancer
Evaluated by documenting the number of participants who develop pancreatic cancer during the follow-up period. The diagnosis is clinically confirmed based on abdominal imaging, specific tumor markers, and/or pathological evaluation.
Measured: Two years
Secondary outcomes (27)
Change in the Morphological Severity of Chronic Pancreatitis
Evaluated using abdominal MRI/MRCP based on the Cambridge classification system. The Cambridge classification grades the severity of chronic pancreatitis based on features such as ductal dilation, strictures, stones, and parenchymal changes. The structural severity is typically graded as normal, equivocal, mild, moderate, or severe. A worse grade indicates more advanced morphological changes.
Measured: Six months
Number of Participants with CT-Detected Morphological Abnormalities or Complications
Evaluated by documenting the number of participants who exhibit at least one of the following specific features on abdominal CT: pancreatic parenchymal calcification, solid masses, suspected malignant lesions, peripancreatic exudation or fluid collection, vascular complications, or progression of pancreatic fibrosis.
Measured: Six months
Number of Participants Requiring Specific ERCP Therapeutic Interventions
Evaluated by documenting the number of participants who undergo one or more specific Endoscopic Retrograde Cholangiopancreatography (ERCP) therapeutic interventions during the follow-up period.
Measured: Six months
Number of Participants with EUS-Detected Pancreatic Microstructural Abnormalities
Evaluated by documenting the number of participants who exhibit specific microstructural changes in the pancreatic parenchyma and pancreatic ducts using Endoscopic Ultrasound (EUS).
Measured: Six months
Change in Traditional Chinese Medicine (TCM) Constitution Scores
Evaluated using a standardized digital TCM instrument, which quantitatively analyzes clinical data to generate scores for 9 standard TCM constitutions. Each of the 9 constitutions is scored on a scale ranging from 0 to 100. Higher scores indicate a stronger inclination toward that specific constitution type.
Measured: Six months
Number of Participants with Clinically Significant Abnormalities in Blood Biochemistry
Evaluated by documenting the number of participants who exhibit clinically significant abnormal values in routine blood biochemistry tests during the follow-up period. The comprehensive monitoring panel includes liver and kidney function, electrolytes, bilirubin, blood lipids, inflammatory markers, and pancreatic enzymes.
Measured: Six months
Change in Sleep Quality Score
Description: Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The total score ranges from 0 to 21. Higher scores indicate worse sleep quality and more severe sleep disturbances.
Measured: Six months
Continuous Glucose Monitoring
A continuous glucose monitoring system is used to assess glucose fluctuations within the target range.
Measured: Two weeks
Change in Gastrointestinal Symptom Rating Scale (GSRS) Score
Gastrointestinal Symptom Rating Scale (GSRS) is used to Core assess the symptoms associated with chronic pancreatitis. The GSRS total score ranges from 15 to 105. Higher scores indicate more severe gastrointestinal symptoms
Measured: Six months
Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Score
Quality of life will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. The index score typically ranges from less than 0 to 1. Higher scores indicate a better health-related quality of life.
Measured: Six months
Change in GAD-7 Score
Patients' anxiety levels will be assessed using the Generalized Anxiety Disorder 7-item (GAD-7) scale. The total score ranges from 0 to 21. Higher scores indicate more severe symptoms of anxiety.
Measured: Six months
Acute Exacerbations of Chronic Pancreatitis
Record the frequency, duration, severity, and treatment outcomes of the patient's acute exacerbations.
Measured: Six months
Complications Within 30 Days After ERCP
Assess the incidence of adverse events, such as postoperative pancreatitis, biliary tract infection, gastrointestinal bleeding, and perforation occurring within 30 days after ERCP.
Measured: One month
Change in Relative Abundance of Key Microbial and Fungal Taxa
Evaluated by analyzing microbiome and specific fungal culture data from samples. The outcome measures the quantitative shift in the relative abundance of targeted microbiota communities.
Measured: Six months
Change in Glycosylated Hemoglobin (HbA1c) Percentage
Pancreatic endocrine function will be evaluated by measuring the percentage of HbA1c in the blood. Higher values indicate poorer long-term glycemic control.
Measured: Six months
Change in Fasting Blood Glucose Concentration
Endocrine function will be evaluated by assessing fasting blood glucose levels. Higher values indicate impaired glucose metabolism or insulin resistance.
Measured: Six months
Change in Fasting Serum Insulin Concentration
Endocrine function will be evaluated by measuring fasting serum insulin levels. Abnormal levels can indicate insulin resistance or impaired pancreatic beta-cell function.
Measured: Six months
Change in Serum C-peptide Concentration
Endocrine function will be evaluated by assessing serum C-peptide levels. C-peptide serves as a reliable biomarker for endogenous insulin production, with lower values indicating decreased pancreatic beta-cell secretory function.
Measured: Six months
Change in Serum Glucagon Concentration
Endocrine function will be evaluated by measuring serum glucagon levels, a hormone produced by pancreatic alpha cells. Abnormal levels reflect dysregulation in glucose counter-regulation.
Measured: Six months
Change in Serum Somatostatin Concentration
Endocrine function will be evaluated by measuring serum somatostatin levels, a hormone produced by pancreatic delta cells that regulates the broader endocrine and digestive systems.
Measured: Six months
Change in Fecal Elastase-1 Concentration
Pancreatic exocrine function will be evaluated by assessing fecal elastase-1 levels. Concentrations below 200 µg/g typically indicate pancreatic exocrine insufficiency (PEI), with lower values reflecting more severe insufficiency.
Measured: Six months
Change in Serum Fat-Soluble Vitamin Concentrations
Pancreatic exocrine function and secondary nutritional status will be evaluated by measuring the serum concentrations of fat-soluble vitamins (e.g., Vitamins A, D, E, and K). Lower values indicate potential fat malabsorption due to exocrine insufficiency.
Measured: Six months
Medical Costs Associated with Unplanned Readmissions
Evaluated by calculating the total direct medical costs incurred by participants due to unplanned hospital readmissions related to chronic pancreatitis.
Measured: Six months
Number of Participants Requiring Surgical or Interventional Procedures During Readmission
Evaluated by documenting the number of participants who require surgical, endoscopic, or other interventional treatments during their unplanned readmission for chronic pancreatitis.
Measured: Six months
Change in PHQ-9 Score
Patients' depression levels will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The total score ranges from 0 to 27. Higher scores indicate more severe symptoms of depression.
Measured: Six months
Change in Concentration of Candidate Metabolites
Evaluated using metabolomics profiling to measure the shift in the concentration of specific metabolite biomarkers.
Measured: Six months
Disease-Associated Multi-Omics Risk Score
Evaluated by integrating high-dimensional multi-omics data derived from multiple biological samples. Advanced statistical modeling, such as LASSO regression and multivariable Cox proportional hazards models, will be applied to construct a composite multi-omics risk signature associated with chronic pancreatitis. The outcome is reported as a continuous multi-omics risk score. Higher scores indicate a greater risk of disease progression and worse clinical outcomes.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start15 Aug 2026 (estimated)
- Primary completion31 Jan 2031 (estimated)
- Study completion31 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Collaborators
- Westlake University
- Responsible party
- Principal investigator, Zhang Xiaofeng,MD, First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770412
- Sponsor's protocol ID
- HZ-BILE-CP-2026
- Acronym
- BILE-CP
- Status last verified
- Aug 2026
- First submitted
- 8 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Biobank Integrating Longitudinal ERCP Within a Prospective Chronic Pancreatitis Cohort
- ClinicalTrials.gov ID
- NCT07770412
- Acronym / sponsor ID
- BILE-CP / HZ-BILE-CP-2026
- Conditions
- Chronic Pancreatitis
- Keywords
- chronic pancreatitis, Endoscopic Retrograde Cholangiopancreatography, multi-omics, ERCP
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Collaborators
- Westlake University
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 31 Jan 2031 (estimated)
- Study completion
- 31 Aug 2031 (estimated)
- First posted
- 18 Aug 2026 (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 Biobank Integrating Longitudinal ERCP within a Prospective Chronic Pancreatitis Cohort (BILE-CP) is a prospective longitudinal cohort study conducted in Hangzhou, Zhejiang Province, China. The study plans to consecutively enroll 1,500 patients with chronic pancreatitis for long-term follow-up (scheduled every 6 months). This cohort encompasses patients across the entire disease course of chronic pancreatitis, with a particular focus on and in-depth tracking of a sub-cohort of patients undergoing ERCP treatments. During baseline and follow-up visits, researchers will collect multidimensional data from participants, including sociodemographics, diet and lifestyle, emotional status and sleep quality, clinical phenotypes and disease characteristics, ERCP intervention details, clinical laboratory and imaging examinations, continuous glucose monitoring (CGM), and traditional Chinese medicine indicators. Concurrently, multi-site biological samples will be collected, including but not limited to blood, feces, bile, saliva, tongue coating, and urine.
Detailed description
Researchers will recruit participants with chronic pancreatitis, with a specific focus on the sub-population undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) interventions. This study aims to construct a prospective longitudinal database that integrates sociodemographics, lifestyle factors, emotional status and sleep quality, clinical phenotypes and disease characteristics, ERCP intervention details, laboratory and imaging examinations, traditional Chinese medicine applications, and multi-site biological samples (including blood, feces, bile, saliva, tongue coating, and urine). The primary objective is to clarify the impact of lifestyle and clinical interventions on the disease progression and stage-specific prognosis of chronic pancreatitis. Concurrently, relying on long-term patient follow-up and repeated biological sample collection, the study will systematically investigate the dynamic evolutionary patterns and underlying mechanisms of the multi-site microbiome during disease progression. By integrating patients' multidimensional information and multi-site multi-omics profiles, the research aims to explore precision management models and key biological mechanisms underlying chronic pancreatitis progression and post-ERCP prognosis. Ultimately, this study expect to provide robust scientific evidence for individualized, precise prevention and clinical decision-making in the management of chronic pancreatitis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BILE-CP Cohort: Patients with Chronic Pancreatitis Meeting Inclusion and Exclusion Criteria | – | Other: This observational cohort study does not involve any interventionsAll eligible patients clinically diagnosed with chronic pancreatitis and receiving standard clinical treatment at the research center. This observational cohort study excludes interventions. And the primary clinical exposure factors of interest include ERCP, lifestyle, and the use of traditional Chinese medicine and herbal remedies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients (aged 18 years and older, regardless of sex) who are clinically diagnosed with chronic pancreatitis and are receiving medical care at the study center (Hangzhou First People's Hospital) in Hangzhou, Zhejiang Province, China.
Key inclusion criteria (5 listed)
- Age ≥ 18 years, with no sex restrictions.
- Meets the diagnostic criteria for chronic pancreatitis, with a definitive diagnosis of chronic pancreatitis based on imaging, pathology, or pancreatic function tests;
- Receiving medical care at the study center and willing to accept long-term follow-up management.
- Able to cooperate with baseline data collection and scheduled follow-ups.
- Provided written informed consent.
Key exclusion criteria (7 listed)
- Concomitant malignancies.
- Concurrent severe systemic diseases with an expected life expectancy of < 1 year.
- History of major pancreatic resection or pancreaticoduodenectomy.
- History of major gastrointestinal surgery.
- Pregnant or lactating population.
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 |
|---|---|---|
| This observational cohort study does not involve any interventionsThis observational cohort study does not involve any interventions | Other | BILE-CP Cohort: Patients with Chronic Pancreatitis Meeting Inclusion and Exclusion Criteria |
Primary outcome
Changes in Exocrine Functions
Time frame: Six months
Evaluated by scores from the pancreatic exocrine insufficiency questionnaire. The calculated final score ranges from 0 to 4. Higher scores indicate more severe symptoms and worse pancreatic exocrine function.
Incidence of Unplanned Readmissions Related to Chronic Pancreatitis and Its Complications
Time frame: Six months
Evaluated by documenting the number of participants who experience at least one unplanned hospital readmission related to chronic pancreatitis and its complications within the follow-up period.
Incidence of Pancreatic Cancer
Time frame: Two years
Evaluated by documenting the number of participants who develop pancreatic cancer during the follow-up period. The diagnosis is clinically confirmed based on abdominal imaging, specific tumor markers, and/or pathological evaluation.
27 secondary outcomes
Change in the Morphological Severity of Chronic Pancreatitis
Time frame: Six months
Number of Participants with CT-Detected Morphological Abnormalities or Complications
Time frame: Six months
Number of Participants Requiring Specific ERCP Therapeutic Interventions
Time frame: Six months
Number of Participants with EUS-Detected Pancreatic Microstructural Abnormalities
Time frame: Six months
Change in Traditional Chinese Medicine (TCM) Constitution Scores
Time frame: Six months
Number of Participants with Clinically Significant Abnormalities in Blood Biochemistry
Time frame: Six months
Change in Sleep Quality Score
Time frame: Six months
Continuous Glucose Monitoring
Time frame: Two weeks
Change in Gastrointestinal Symptom Rating Scale (GSRS) Score
Time frame: Six months
Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Score
Time frame: Six months
Change in GAD-7 Score
Time frame: Six months
Acute Exacerbations of Chronic Pancreatitis
Time frame: Six months
Complications Within 30 Days After ERCP
Time frame: One month
Change in Relative Abundance of Key Microbial and Fungal Taxa
Time frame: Six months
Change in Glycosylated Hemoglobin (HbA1c) Percentage
Time frame: Six months
Change in Fasting Blood Glucose Concentration
Time frame: Six months
Change in Fasting Serum Insulin Concentration
Time frame: Six months
Change in Serum C-peptide Concentration
Time frame: Six months
Change in Serum Glucagon Concentration
Time frame: Six months
Change in Serum Somatostatin Concentration
Time frame: Six months
Change in Fecal Elastase-1 Concentration
Time frame: Six months
Change in Serum Fat-Soluble Vitamin Concentrations
Time frame: Six months
Medical Costs Associated with Unplanned Readmissions
Time frame: Six months
Number of Participants Requiring Surgical or Interventional Procedures During Readmission
Time frame: Six months
Change in PHQ-9 Score
Time frame: Six months
Change in Concentration of Candidate Metabolites
Time frame: Six months
Disease-Associated Multi-Omics Risk Score
Time frame: Six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Pancreatitis
RecruitingPhase 1
Metabolic Impact of Pancreatic Duct Decompression
Chronic Pancreatitis
RecruitingPhase 1
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of CBT-248 in Healthy Adult Participants
Chronic Pancreatitis
Not yet recruitingObservational study
AI-Assisted Differentiation of Autoimmune Pancreatitis and Pancreatic Cancer Using EUS: A Multicenter Ambispective Study
Autoimmune Pancreatitis, Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Comparative Study to Evaluate Microbial Versus Porcine Pancreatic Enzyme Therapy in Chronic Pancreatitis
Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency (EPI)
Active, not recruitingPhase 4
A Study Of Effect Of Secretin For In Injection (Chirostim) On Pancreatic Fluid Composition In Healthy Subjects
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
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.
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 First People's Hospital of Hangzhou 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 5 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: opening soon, as of the sponsor's last update on 18 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaofeng Zhang (86-0571-56005600, zhangxiaofeng@hospital.westlake.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Exocrine Functions (time frame: Six months). The study lists 3 primary outcomes in all. 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 18 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.