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临床试验/NCT07074379
NCT07074379招募中不适用

Endotherapy and/or Extracorporeal Shockwave Lithotripsy Versus Conservative Treatment in Painless Chronic Pancreatitis

Changhai Hospital1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2025年7月21日最近更新:
干预措施
相关药物

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

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

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.

排除标准

  • Presence of complications requiring endoscopic or surgical intervention, such as pancreatic pseudocysts, benign biliary strictures, or pancreatic fistulas.
  • 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

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 such as endoscopic retrograde cholangiopancreatography (ERCP) and/or extracorporeal shockwave lithotripsy (ESWL).

干预措施: Lifestyle modifications (Behavioral)

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 such as endoscopic retrograde cholangiopancreatography (ERCP) and/or extracorporeal shockwave lithotripsy (ESWL).

干预措施: Pancreatic enzyme (Pancreatin Enteric-coated Capsules or Oryz-Aspergillus Enzyme and Pancreatin Table), antidiabetic medicine(Acarbose , Metformin, Glimepirde Tablets, Insulin) (Drug)

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 such as endoscopic retrograde cholangiopancreatography (ERCP) and/or extracorporeal shockwave lithotripsy (ESWL).

干预措施: Endoscopic Retrograde Cholangiopancreatography (ERCP) and/or Extracorporeal Shockwave Lithotripsy (ESWL) (Procedure)

Conservative Treatment Group

Active Comparator

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).

干预措施: Lifestyle modifications (Behavioral)

Conservative Treatment Group

Active Comparator

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).

干预措施: Pancreatic enzyme (Pancreatin Enteric-coated Capsules or Oryz-Aspergillus Enzyme and Pancreatin Table), antidiabetic medicine(Acarbose , Metformin, Glimepirde Tablets, Insulin) (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

  • 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)
  • Pancreatic Exocrine Function(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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhaoshen Li

Professor

Changhai Hospital

研究点 (1)

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