Endotherapy and/or Extracorporeal Shockwave Lithotripsy for Painless Chronic Pancreatitis

NCT07074379 | Recruiting DMC

• 2 other identifiers: CHEC2025-268CHEC2026-307
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Painless Chronic Pancreatitis

Outcome Measures

Primary Outcomes (1)

• Acute Pancreatitis Incidence

  The incidence of acute pancreatitis assessed by Revised Atlanta Classification over a 12-month period following randomization.

  12 months

Secondary Outcomes (22)

• Severity of Acute Pancreatitis

  12 months

• Incidence and Severity of Pancreatic Pain

  12 months

• Number of Acute Pancreatitis Episodes

  12 months

• Number of pancreatic pain episodes

  12 months

• Fecal Elastase-1 Level

  12 months

Other Outcomes (1)

• Long-term Outcome Assessment

  3, 5, and 10 years post-randomization

Study Arms (2)

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.

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.

Behavioral: Lifestyle modifications; Drug: Pancreatic enzyme replacement therapy (PERT) and glycemic control therapy

Interventions

Lifestyle modifications BEHAVIORAL

Lifestyle modifications primarily include quitting smoking and alcohol consumption, as well as engaging in physical exercise.

Conservative Treatment Group; Endotherapy and/or Extracorporeal Shockwave Lithotripsy Group

Endoscopic Retrograde Cholangiopancreatography (ERCP) and/or Extracorporeal Shockwave Lithotripsy (ESWL) PROCEDURE

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.

Endotherapy and/or Extracorporeal Shockwave Lithotripsy Group

Pancreatic enzyme replacement therapy (PERT) and glycemic control therapy DRUG

This 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).

Conservative Treatment Group; Endotherapy and/or Extracorporeal Shockwave Lithotripsy Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Interventions

Cholangiopancreatography, Endoscopic Retrograde; Lithotripsy

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Therapeutics; Ultrasonic Surgical Procedures

Central Study Contacts

Zhao-Shen Li

CONTACT

+8613901960921; zhaoshen-li@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 20, 2025
• Study Start: July 21, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): July 1, 2037
• Last Updated: September 23, 2026

Record last verified: 2026-09

Locations

CN (1)