Endotherapy and/or Extracorporeal Shockwave Lithotripsy Versus Conservative Treatment in Painless Chronic Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Acute Pancreatitis Incidence
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Conservative Treatment Group
This arm includes participants who will receive standard conservative management for painless chronic pancreatitis.
- 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).
- 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.
- 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
- Surgery will be performed for mass-forming chronic pancreatitis with inconclusive diagnosis.
干预措施: Lifestyle modifications (Behavioral)
Endotherapy and/or Extracorporeal Shockwave Lithotripsy Group
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).
- For main pancreatic duct strictures persisting after initial single plastic stent placement for one year, multiple stents or surgery may be considered.
- 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.
- 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
- Surgery will be performed for mass-forming chronic pancreatitis with inconclusive diagnosis.
干预措施: Lifestyle modifications (Behavioral)
Endotherapy and/or Extracorporeal Shockwave Lithotripsy Group
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).
- For main pancreatic duct strictures persisting after initial single plastic stent placement for one year, multiple stents or surgery may be considered.
- 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.
- 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
- Surgery will be performed for mass-forming chronic pancreatitis with inconclusive diagnosis.
干预措施: Endoscopic Retrograde Cholangiopancreatography (ERCP) and/or Extracorporeal Shockwave Lithotripsy (ESWL) (Procedure)
Endotherapy and/or Extracorporeal Shockwave Lithotripsy Group
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).
- For main pancreatic duct strictures persisting after initial single plastic stent placement for one year, multiple stents or surgery may be considered.
- 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.
- 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
- Surgery will be performed for mass-forming chronic pancreatitis with inconclusive diagnosis.
干预措施: Pancreatic enzyme replacement therapy (PERT) and glycemic control therapy (Drug)
Conservative Treatment Group
This arm includes participants who will receive standard conservative management for painless chronic pancreatitis.
- 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).
- 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.
- 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
- Surgery will be performed for mass-forming chronic pancreatitis with inconclusive diagnosis.
干预措施: Pancreatic enzyme replacement therapy (PERT) and glycemic control therapy (Drug)
结局指标
主要结局
Acute Pancreatitis Incidence
时间窗: 12 months
The incidence of acute pancreatitis assessed by Revised Atlanta Classification over a 12-month period following randomization.
次要结局
- Number of Acute Pancreatitis Episodes(12 months)
- Number of pancreatic pain episodes(12 months)
- Fecal Elastase-1 Level(12 months)
- Fasting Insulin Concentration(12 months)
- Rate of Pancreatic Exocrine Insufficiency(12 months)
- Rate of Pancreatic Endocrine Insufficiency(12 months)
- Change of Pancreatic Exocrine and Endocrine Function Status From Baseline(12 months)
- Rate of Disease Progression(12 months)
- Incidence and Severity of Pancreatic Pain(12 months)
- Glycosylated Hemoglobin Level(12 months)
- Fasting Blood Glucose Level(12 months)
- Glucose Area Under the Curve (AUC) Post MMTT(12 months)
- Insulin Area Under the Curve (AUC) Post MMTT(12 months)
- Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)(12 months)
- Severity of Acute Pancreatitis(12 months)
- Fasting C-Peptide Concentration(12 months)
- C-peptide Area Under the Curve (AUC) Post MMTT(12 months)
- Disposition Index for C-peptide(12 months)
- Quality of Life Assessed by SF-36(12 months)
- Homeostatic Model Assessment of β-cell Function (HOMA-b)(12 months)
- Insulinogenic Index Post MMTT(12 months)
- C-peptide Secretion Index Post MMTT(12 months)