Painless Chronic PancreatitisPCPNCT07074379
Endotherapy and/or Extracorporeal Shockwave Lithotripsy for Painless Chronic Pancreatitis
A study testing Lifestyle modifications and Endoscopic Retrograde Cholangiopancreatography (ERCP) and/or Extracorporeal Shockwave Lithotripsy (ESWL) in people with Painless Chronic Pancreatitis, run by Changhai Hospital at 1 site in China.
Trial summary
Chronic pancreatitis (CP) is caused by factors such as genetics and the environment, leading to the destruction of pancreatic tissue, infiltration of inflammatory cells, and progressive fibrosis of the pancreas. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Painless Chronic Pancreatitis
- What is being tested?
- Lifestyle modifications and Endoscopic Retrograde Cholangiopancreatography (ERCP) and/or Extracorporeal Shockwave Lithotripsy (ESWL)
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 21 Jul 2025to 1 Jul 2037
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-85 years.
- Diagnosed with painless chronic pancreatitis.
- No prior history of endoscopic retrograde cholangiopancreatography (ERCP) or extracorporeal shockwave lithotripsy (ESWL) treatment.
- Stone(s) in the cephalic or corporeal portion of the main pancreatic duct with upstream duct dilation
Who cannot join
- Presence of complications requiring endoscopic or surgical intervention, such as pancreatic pseudocysts, benign biliary strictures, pancreatic fistulas, or pancreatic portal hypertension.
- Autoimmune pancreatitis.
- Suspected malignancy.
- History of pancreatic surgery or gastrointestinal bypass surgery (e.g., Billroth II procedure).
- End-stage disease.
- Pregnancy or lactation.
- Contraindications to ESWL or ERCP.
- Refusal to provide informed consent.
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, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Zhao-Shen Li, M.D., +8613901960921, zhaoshen-li@hotmail.com
About this study
Official title: Endotherapy and/or Extracorporeal Shockwave Lithotripsy Versus Conservative Treatment in Painless Chronic Pancreatitis
Chronic pancreatitis (CP) is caused by factors such as genetics and the environment, leading to the destruction of pancreatic tissue, infiltration of inflammatory cells, and progressive fibrosis of the pancreas. As the disease progresses, pancreatic tissue is damaged, resulting in impaired endocrine and exocrine functions, manifesting as symptoms like steatorrhea and diabetes. Pain associated with chronic pancreatitis (PACP) is the most common symptom in CP patients. Approximately 75% of patients initially present with abdominal pain, and previous studies have shown that PACP can occur in 85-97% of CP patients. However, there is a type of pancreatitis where patients do not experience abdominal pain and typically seek medical attention due to routine check-ups or symptoms of pancreatic endocrine and exocrine dysfunction; this particular type of pancreatitis is known as painless CP. A meta-analysis showed that painless CP accounts for about 12% of all CP patients.
In patients with CP, continuous pancreatic damage leads to the destruction of pancreatic tissue, subsequently causing insufficiency in both exocrine and endocrine functions. "Painless" does not equate to "harmless"; patients with painless CP often present with severe symptoms of pancreatic exocrine and endocrine dysfunction at the time of diagnosis. These findings underscore the importance of early identification and active management of patients with painless CP.
Read more
Whether active endoscopic intervention is needed for painless CP remains a matter of debate. The European Society of Gastrointestinal Endoscopy (ESGE) suggests endoscopic therapy and/or extracorporeal shockwave lithotripsy (ESWL) as the first-line therapy for painful uncomplicated chronic pancreatitis (CP) with an obstructed main pancreatic duct (MPD) in the head/ body of the pancreas; however, due to the unclear potential benefits (preservation of pancreatic function) of endoscopic and/or ESWL treatment for painless CP, it is not recommended for patients without pain, although the evidence is of low quality.
Although there is currently no consensus on whether endoscopic treatment can protect the pancreatic function of patients with painless chronic pancreatitis, preliminary evidence suggests that endoscopic treatment may have a positive impact on pancreatic atrophy and dysfunction in patients with painless CP. In a retrospective study by Ikeura et al., which included 268 patients with CP and painless pancreatic duct stones, it was found that endoscopic treatment and complete clearance of stones in patients with painless pancreatic duct stones helped maintain the volume of the pancreatic parenchyma.
Although preliminary research suggests that endoscopic treatment may protect pancreatic function in patients with painless CP, it could also trigger pain. A study by Ikeura et al. found that painless CP patients who underwent endoscopic treatment but did not have complete clearance of pancreatic duct stones were at a significantly higher risk of developing pain. This indicates that incomplete endoscopic treatment might lead patients from a painless state to one of pain. However, a study by Amodio et al. suggests that the likelihood of painless CP patients experiencing pain in the short term is low, implying that conservative treatment might be more appropriate.
Current research on the clinical characteristics of painless CP and its response to treatment is relatively limited, necessitating further clinical studies to clarify the impact of ERCP and/or ESWL on these patients. We plan to conduct a randomized controlled trial to assess whether these minimally invasive interventions can improve clinical outcomes for patients with painless CP
Read the detailed description
This is a randomized controlled trial comparing endotherapy combined with extracorporeal shock-wave lithotripsy (ESWL) versus conservative management in participants with painless chronic pancreatitis. A total of 126 eligible participants will be randomized 1:1 to either the endotherapy-plus-ESWL arm or the conservative-treatment arm. The primary endpoint will be evaluated at 1-year follow-up. And participants will enter long-term follow-up up to 10 years post-randomization.
- Conditions
- Painless Chronic Pancreatitis
- Being tested
- Lifestyle modifications, Pancreatic enzyme replacement therapy (PERT) and glycemic control therapy, Endoscopic Retrograde Cholangiopancreatography (ERCP) and/or Extracorporeal Shockwave Lithotripsy (ESWL)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle modificationsBehavioural
Lifestyle modifications primarily include quitting smoking and alcohol consumption, as well as engaging in physical exercise.
Pancreatic enzyme replacement therapy (PERT) and glycemic control therapyDrug
This intervention involves the use of medications to control the pancreatic exocrine and endocrine dysfunction caused by chronic pancreatitis.
- Pancreatic enzyme therapy: Patients will use pancreatic enzymes (pancreatin enteric-coated capsules or oryz-aspergillus enzyme and pancreatin tablets) to control the symptoms of exocrine pancreatic insufficiency.
- Diabetes treatment: Patients with diabetes will also use antidiabetic medications (such as oral hypoglycemic drugs or insulin, depending on glycemic control needs).
Endoscopic Retrograde Cholangiopancreatography (ERCP) and/or Extracorporeal Shockwave Lithotripsy (ESWL)Procedure or surgery
This intervention involves the application of endoscopic retrograde cholangiopancreatography (ERCP) and/or extracorporeal shockwave lithotripsy (ESWL). The procedures are tailored to the individual patient's condition, which may include sphincterotomy, dilation of pancreatic duct strictures, stone extraction, stent placement and other interventions as indicated. ESWL may be used prior to ERCP to fragment pancreatic duct stones, facilitating their removal.
| Study group | Role | What they receive |
|---|---|---|
| Endotherapy and/or Extracorporeal Shockwave Lithotripsy Group | Experimental | Participants in this arm will undergo a comprehensive treatment approach that includes lifestyle modifications, pharmacological interventions, and procedural therapies including ERCP and/or extracorporeal shock-wave lithotripsy (ESWL).
1. For main pancreatic duct strictures persisting after initial single plastic stent placement for one year, multiple stents or surgery may be considered.
2. During follow-up, if pancreatic pain or acute pancreatitis occurs, a multidisciplinary team will assess attack frequency and clinical severity and decide whether repeat minimally invasive therapy is indicated.
3. If CP-related complications (including pancreatic pseudocyst, biliary stricture, pancreatic portal hypertension, pancreatic fistula, etc.) occur and meet intervention indications, endoscopic or surgical intervention will be performed in accordance with clinical guidelines
4. Surgery will be performed for mass-forming chronic pancreatitis with inconclusive diagnosis. Receives: Behavioral: Lifestyle modifications; Drug: Pancreatic enzyme replacement therapy (PERT) and glycemic control therapy; Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP) and/or Extracorporeal Shockwave Lithotripsy (ESWL) |
| Conservative Treatment Group | Active comparator | This arm includes participants who will receive standard conservative management for painless chronic pancreatitis.
1. The treatment regimen comprises lifestyle modification and medications to manage symptoms of pancreatic exocrine and endocrine insufficiency, such as pancreatic enzyme supplements and medications for diabetes management (e.g., oral hypoglycemics or insulin).
2. During follow-up, if pancreatic pain or acute pancreatitis occurs, a multidisciplinary team will assess attack frequency and clinical severity and decide whether minimally invasive therapy is indicated.
3. If CP-related complications (including pancreatic pseudocyst, biliary stricture, pancreatic portal hypertension, pancreatic fistula, etc.) occur and meet intervention indications, endoscopic or surgical intervention will be performed in accordance with clinical guidelines
4. Surgery will be performed for mass-forming chronic pancreatitis with inconclusive diagnosis. Receives: Behavioral: Lifestyle modifications; Drug: Pancreatic enzyme replacement therapy (PERT) and glycemic control therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Pancreatitis Incidence
The incidence of acute pancreatitis assessed by Revised Atlanta Classification over a 12-month period following randomization.
Measured: 12 months
Secondary outcomes (22)
Severity of Acute Pancreatitis
The severity of acute pancreatitis episodes that occur within 12 months post randomization. Severity will be graded according to the Atlanta Classification criteria, which categorizes pancreatitis into mild, moderate, and severe based on clinical and imaging findings.
Measured: 12 months
Incidence and Severity of Pancreatic Pain
The incidence and severity of pancreatic pain over a 12-month period. Pain severity will be measured using the Visual Analogue Scale (VAS), where patients rate their pain on a scale from 0 (no pain) to 10 (worst possible pain).
Measured: 12 months
Number of Acute Pancreatitis Episodes
Measured: 12 months
Number of pancreatic pain episodes
Measured: 12 months
Fecal Elastase-1 Level
This outcome assesses pancreatic exocrine function by measuring fecal elastase-1 (FE-1) levels
Measured: 12 months
Glycosylated Hemoglobin Level
This outcome measure evaluates the percentage of hemoglobin that is glycosylated, reflecting the average blood glucose levels over the past 2 to 3 months. It is a key indicator of long-term glycose level in patients.
Measured: 12 months
Fasting Blood Glucose Level
This outcome measure assesses the level of glucose in the blood after an overnight fast. Fasting glucose is a standard test for diagnosing diabetes and monitoring diabetes control. It provides a snapshot of the body's ability to manage glucose without the influence of food.
Measured: 12 months
Fasting C-Peptide Concentration
This outcome measure determines the concentration of C-peptide in the blood during a fasting state. C-peptide is a byproduct of insulin production and provides an index of endogenous insulin secretion. It is useful for assessing insulin production capacity.
Measured: 12 months
Fasting Insulin Concentration
Measured: 12 months
C-peptide Area Under the Curve (AUC) Post MMTT
This outcome measures the total exposure to C-peptide over the first 2 hours following a mixed meal tolerance test (MMTT). The AUC is calculated using Riemann sums based on the midpoint of each interval (0, 30, 60, 90, and 120 minutes). This metric is crucial for assessing the overall insulin secretion capacity of the islets.
Measured: 12 months
Glucose Area Under the Curve (AUC) Post MMTT
This outcome assesses the total glucose exposure over the first 2 hours following a Mixed Meal Tolerance Test (MMTT). The AUC is determined using Riemann sums based on the midpoint of each interval (0, 30, 60, 90, and 120 minutes). This metric is essential for evaluating the body's glucose handling ability and the effectiveness of glucose control.
Measured: 12 months
Insulin Area Under the Curve (AUC) Post MMTT
This outcome measures the total insulin exposure over the first 2 hours following a Mixed Meal Tolerance Test (MMTT). The AUC is calculated using Riemann sums based on the midpoint of each interval (0, 30, 60, 90, and 120 minutes). This metric is vital for assessing the overall insulin secretion response to a meal and the effectiveness of insulin production.
Measured: 12 months
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
The HOMA-IR is calculated from fasting glucose and fasting insulin levels obtained during the MMTT. It provides an estimate of insulin resistance and is calculated using the formula: HOMA-IR= (fasting glucose × fasting insulin)/405. This index is crucial for understanding the body's insulin sensitivity.
Measured: 12 months
Homeostatic Model Assessment of β-cell Function (HOMA-b)
HOMA-b is determined by the formula HOMA b = (fasting insulin × 360)/(fasting glucose - 63) to assess insulin secretion. It provides an estimate of the β-cell function in response to fasting glucose levels.
Measured: 12 months
Insulinogenic Index Post MMTT
The insulinogenic index is a measure of the early insulin response to a glucose challenge, calculated as (Δinsulin30-0min / Δglucose30-0min). It reflects the capacity of the β-cells to secrete insulin in response to a rise in blood glucose levels.
Measured: 12 months
C-peptide Secretion Index Post MMTT
This index is calculated by replacing insulin with C-peptide in the insulinogenic index formula, i.e., (ΔC-peptide30-0min / Δglucose30-0min). It serves as a measure of the early C-peptide response to a glucose challenge, providing information about the secretory capacity of the islets.
Measured: 12 months
Disposition Index for C-peptide
The disposition index for C-peptide is calculated as (ΔC-peptide30-0min / Δglucose30-0min) × (1 / fasting C-peptide). It represents the ratio of insulin or C-peptide secretion to sensitivity and is an important indicator of the overall β-cell function and insulin sensitivity.
Measured: 12 months
Rate of Pancreatic Exocrine Insufficiency
Derived outcome based on fecal elastase-1 measurement
Measured: 12 months
Rate of Pancreatic Endocrine Insufficiency
Derived endocrine functional status based on fasting glucose, HbA1c and mixed-meal tolerance test.
Measured: 12 months
Change of Pancreatic Exocrine and Endocrine Function Status From Baseline
Categorical change in pancreatic functional status relative to baseline: persistent insufficiency, new-onset insufficiency, resolution of pre-existing insufficiency, persistently normal pancreatic function.
Measured: 12 months
Rate of Disease Progression
Proportion of participants with new-onset chronic-pancreatitis-related complications, including pancreatic pseudocysts, benign biliary strictures, pancreatic fistulas, pancreatic portal hypertension, and other related complications
Measured: 12 months
Quality of Life Assessed by SF-36
This outcome evaluates the quality of life (QoL) of patients with painless chronic pancreatitis at two time points: at baseline (time of hospital admission) and at 12 months post-randomization. The assessment is conducted using the Short Form Health Survey (SF-36), a widely recognized and validated tool that measures health-related quality of life across eight dimensions: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The SF-36 provides a comprehensive overview of how the condition and treatment affect the patients' overall well-being and daily functioning.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start21 Jul 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jul 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painless 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074379
- Sponsor's protocol ID
- CHEC2025-268
- Other IDs
- CHEC2026-307
- Acronym
- PCP
- Status last verified
- Sep 2026
- First submitted
- 29 Jun 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endotherapy and/or Extracorporeal Shockwave Lithotripsy Versus Conservative Treatment in Painless Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT07074379
- Acronym / sponsor ID
- PCP / CHEC2025-268
- Conditions
- Painless Chronic Pancreatitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jul 2037 (estimated)
- First posted
- 20 Jul 2025 (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.
Chronic pancreatitis (CP) is caused by factors such as genetics and the environment, leading to the destruction of pancreatic tissue, infiltration of inflammatory cells, and progressive fibrosis of the pancreas. As the disease progresses, pancreatic tissue is damaged, resulting in impaired endocrine and exocrine functions, manifesting as symptoms like steatorrhea and diabetes. Pain associated with chronic pancreatitis (PACP) is the most common symptom in CP patients. Approximately 75% of patients initially present with abdominal pain, and previous studies have shown that PACP can occur in 85-97% of CP patients. However, there is a type of pancreatitis where patients do not experience abdominal pain and typically seek medical attention due to routine check-ups or symptoms of pancreatic endocrine and exocrine dysfunction; this particular type of pancreatitis is known as painless CP. A meta-analysis showed that painless CP accounts for about 12% of all CP patients.
In patients with CP, continuous pancreatic damage leads to the destruction of pancreatic tissue, subsequently causing insufficiency in both exocrine and endocrine functions. "Painless" does not equate to "harmless"; patients with painless CP often present with severe symptoms of pancreatic exocrine and endocrine dysfunction at the time of diagnosis. These findings underscore the importance of early identification and active management of patients with painless CP.
Whether active endoscopic intervention is needed for painless CP remains a matter of debate. The European Society of Gastrointestinal Endoscopy (ESGE) suggests endoscopic therapy and/or extracorporeal shockwave lithotripsy (ESWL) as the first-line therapy for painful uncomplicated chronic pancreatitis (CP) with an obstructed main pancreatic duct (MPD) in the head/ body of the pancreas; however, due to the unclear potential benefits (preservation of pancreatic function) of endoscopic and/or ESWL treatment for painless CP, it is not recommended for patients without pain, although the evidence is of low quality.
Although there is currently no consensus on whether endoscopic treatment can protect the pancreatic function of patients with painless chronic pancreatitis, preliminary evidence suggests that endoscopic treatment may have a positive impact on pancreatic atrophy and dysfunction in patients with painless CP. In a retrospective study by Ikeura et al., which included 268 patients with CP and painless pancreatic duct stones, it was found that endoscopic treatment and complete clearance of stones in patients with painless pancreatic duct stones helped maintain the volume of the pancreatic parenchyma.
Although preliminary research suggests that endoscopic treatment may protect pancreatic function in patients with painless CP, it could also trigger pain. A study by Ikeura et al. found that painless CP patients who underwent endoscopic treatment but did not have complete clearance of pancreatic duct stones were at a significantly higher risk of developing pain. This indicates that incomplete endoscopic treatment might lead patients from a painless state to one of pain. However, a study by Amodio et al. suggests that the likelihood of painless CP patients experiencing pain in the short term is low, implying that conservative treatment might be more appropriate.
Current research on the clinical characteristics of painless CP and its response to treatment is relatively limited, necessitating further clinical studies to clarify the impact of ERCP and/or ESWL on these patients. We plan to conduct a randomized controlled trial to assess whether these minimally invasive interventions can improve clinical outcomes for patients with painless CP
Detailed description
This is a randomized controlled trial comparing endotherapy combined with extracorporeal shock-wave lithotripsy (ESWL) versus conservative management in participants with painless chronic pancreatitis. A total of 126 eligible participants will be randomized 1:1 to either the endotherapy-plus-ESWL arm or the conservative-treatment arm. The primary endpoint will be evaluated at 1-year follow-up. And participants will enter long-term follow-up up to 10 years post-randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endotherapy and/or Extracorporeal Shockwave Lithotripsy Group | Experimental | Behavioral: Lifestyle modifications, Drug: Pancreatic enzyme replacement therapy (PERT) and glycemic control therapy, Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP) and/or Extracorporeal Shockwave Lithotripsy (ESWL)Participants in this arm will undergo a comprehensive treatment approach that includes lifestyle modifications, pharmacological interventions, and procedural therapies including ERCP and/or extracorporeal shock-wave lithotripsy (ESWL). 1. For main pancreatic duct strictures persisting after initial single plastic stent placement for one year, multiple stents or surgery may be considered. 2. During follow-up, if pancreatic pain or acute pancreatitis occurs, a multidisciplinary team will assess attack frequency and clinical severity and decide whether repeat minimally invasive therapy is indicated. 3. If CP-related complications (including pancreatic pseudocyst, biliary stricture, pancreatic portal hypertension, pancreatic fistula, etc.) occur and meet intervention indications, endoscopic or surgical intervention will be performed in accordance with clinical guidelines 4. Surgery will be performed for mass-forming chronic pancreatitis with inconclusive diagnosis. |
| Conservative Treatment Group | Active comparator | Behavioral: Lifestyle modifications, Drug: Pancreatic enzyme replacement therapy (PERT) and glycemic control therapyThis arm includes participants who will receive standard conservative management for painless chronic pancreatitis. 1. The treatment regimen comprises lifestyle modification and medications to manage symptoms of pancreatic exocrine and endocrine insufficiency, such as pancreatic enzyme supplements and medications for diabetes management (e.g., oral hypoglycemics or insulin). 2. During follow-up, if pancreatic pain or acute pancreatitis occurs, a multidisciplinary team will assess attack frequency and clinical severity and decide whether minimally invasive therapy is indicated. 3. If CP-related complications (including pancreatic pseudocyst, biliary stricture, pancreatic portal hypertension, pancreatic fistula, etc.) occur and meet intervention indications, endoscopic or surgical intervention will be performed in accordance with clinical guidelines 4. Surgery will be performed for mass-forming chronic pancreatitis with inconclusive diagnosis. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18-85 years.
- Diagnosed with painless chronic pancreatitis.
- No prior history of endoscopic retrograde cholangiopancreatography (ERCP) or extracorporeal shockwave lithotripsy (ESWL) treatment.
- Stone(s) in the cephalic or corporeal portion of the main pancreatic duct with upstream duct dilation
Key exclusion criteria (8 listed)
- Presence of complications requiring endoscopic or surgical intervention, such as pancreatic pseudocysts, benign biliary strictures, pancreatic fistulas, or pancreatic portal hypertension.
- Autoimmune pancreatitis.
- Suspected malignancy.
- History of pancreatic surgery or gastrointestinal bypass surgery (e.g., Billroth II procedure).
- End-stage disease.
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 |
|---|---|---|
| Lifestyle modificationsLifestyle modifications primarily include quitting smoking and alcohol consumption, as well as engaging in physical exercise. | Behavioural | Conservative Treatment Group, Endotherapy and/or Extracorporeal Shockwave Lithotripsy Group |
| Pancreatic enzyme replacement therapy (PERT) and glycemic control therapyThis intervention involves the use of medications to control the pancreatic exocrine and endocrine dysfunction caused by chronic pancreatitis. 1. Pancreatic enzyme therapy: Patients will use pancreatic enzymes (pancreatin enteric-coated capsules or oryz-aspergillus enzyme and pancreatin tablets) to control the symptoms of exocrine pancreatic insufficiency. 2. Diabetes treatment: Patients with diabetes will also use antidiabetic medications (such as oral hypoglycemic drugs or insulin, depending on glycemic control needs). | Drug | Conservative Treatment Group, Endotherapy and/or Extracorporeal Shockwave Lithotripsy Group |
| Endoscopic Retrograde Cholangiopancreatography (ERCP) and/or Extracorporeal Shockwave Lithotripsy (ESWL)This intervention involves the application of endoscopic retrograde cholangiopancreatography (ERCP) and/or extracorporeal shockwave lithotripsy (ESWL). The procedures are tailored to the individual patient's condition, which may include sphincterotomy, dilation of pancreatic duct strictures, stone extraction, stent placement and other interventions as indicated. ESWL may be used prior to ERCP to fragment pancreatic duct stones, facilitating their removal. | Procedure or surgery | Endotherapy and/or Extracorporeal Shockwave Lithotripsy Group |
Primary outcome
Acute Pancreatitis Incidence
Time frame: 12 months
The incidence of acute pancreatitis assessed by Revised Atlanta Classification over a 12-month period following randomization.
22 secondary outcomes
Severity of Acute Pancreatitis
Time frame: 12 months
Incidence and Severity of Pancreatic Pain
Time frame: 12 months
Number of Acute Pancreatitis Episodes
Time frame: 12 months
Number of pancreatic pain episodes
Time frame: 12 months
Fecal Elastase-1 Level
Time frame: 12 months
Glycosylated Hemoglobin Level
Time frame: 12 months
Fasting Blood Glucose Level
Time frame: 12 months
Fasting C-Peptide Concentration
Time frame: 12 months
Fasting Insulin Concentration
Time frame: 12 months
C-peptide Area Under the Curve (AUC) Post MMTT
Time frame: 12 months
Glucose Area Under the Curve (AUC) Post MMTT
Time frame: 12 months
Insulin Area Under the Curve (AUC) Post MMTT
Time frame: 12 months
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: 12 months
Homeostatic Model Assessment of β-cell Function (HOMA-b)
Time frame: 12 months
Insulinogenic Index Post MMTT
Time frame: 12 months
C-peptide Secretion Index Post MMTT
Time frame: 12 months
Disposition Index for C-peptide
Time frame: 12 months
Rate of Pancreatic Exocrine Insufficiency
Time frame: 12 months
Rate of Pancreatic Endocrine Insufficiency
Time frame: 12 months
Change of Pancreatic Exocrine and Endocrine Function Status From Baseline
Time frame: 12 months
Rate of Disease Progression
Time frame: 12 months
Quality of Life Assessed by SF-36
Time frame: 12 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 23 Sep 2026.
- Individual participant dataSharing planned: Undecided
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?
A study testing Lifestyle modifications and Endoscopic Retrograde Cholangiopancreatography (ERCP) and/or Extracorporeal Shockwave Lithotripsy (ESWL) in people with Painless 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 23 Sep 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 Zhao-Shen Li (+8613901960921, zhaoshen-li@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Pancreatitis Incidence (time frame: 12 months). 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 23 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.