NCT07074379 Endotherapy and/or Extracorporeal Shockwave Lithotripsy for Painless Chronic Pancreatitis
| NCT ID | NCT07074379 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Changhai Hospital |
| Condition | Painless Chronic Pancreatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 126 participants |
| Start Date | 2025-07-21 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 126 participants in total. It began in 2025-07-21 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07074379 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Painless Chronic Pancreatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07074379 currently recruiting?
Yes, NCT07074379 is actively recruiting participants. Contact the research team at zhaoshen-li@hotmail.com for enrollment information.
Where is the NCT07074379 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07074379 clinical trial?
NCT07074379 is sponsored by Changhai Hospital. The trial plans to enroll 126 participants.