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临床试验/NCT05261997
NCT05261997Unknown不适用

Effect of Endotherapy on the Progression of Chronic Pancreatitis in Painless Patients

Changhai Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
exocrine function of the pancreas assessed by the value of fecal elastase in μg/g

研究概览

简要总结

This is a prospective randomized controlled trial. . Patients will be divided into conservative or endoscopic group and fecal pancreatic elastase-1 (FE-1) is tested to evaluate pancreatic exocrine function. The effect of extracorporeal shock wave lithotripsy and endoscopic treatment on the progression of chronic pancreatitis in painless patients will be determined.

详细描述

This is a prospective, randomized controlled trial. Patients will be divided into conservative or endoscopic group and FE-1 is tested to evaluate pancreatic exocrine function. The effect of extracorporeal shock wave lithotripsy and endoscopic treatment on the progression of chronic pancreatitis in painless patients will be determined.

Chronic pancreatitis (CP) is a pathologic fibro-inflammatory syndrome of the pancreas that eventually leads to damage of the gland in individuals with genetic, environmental and/or other risk factors. If widespread, this damage causes failure of exocrine and endocrine pancreatic function resulting in steatorrhea and diabetes. The global pooled incidence of CP is 10 cases [95% Confidence interval (CI) 8-12] per 100,000 general population per year. Endoscopic retrograde cholangiopancreatography (ERCP) and extracorporeal shock wave lithotripsy (ESWL) has become first-line therapy for patients with chronic pancreatitis according to guidelines. Endoscopic therapy has been proved effective and safe. The clearance rate of pancreatic stones was 42-76%, and the pain relief rate was 15-85%.

Pain is the major clinical features of CP and remained a major clinical challenge. It is present in up to 90% of patients and is the main cause of hospitalization in most patients.Patten of pain for patients with chronic pancreatitis differs widely.

However, some CP patients have never had abdominal pain during the course of the disease, and participants are often diagnosed with CP due to diabetes or steatorrhea, which are called painless CP, accounting for about 10% of the CP population. These patients are mainly characterized as pancreatic endocrine and exocrine insufficiency. Some studies proposed that painless CP may be related to the severity of inflammation and the pain sensitivity of patients, but the mechanism has not yet been elucidated.

It is still controversial whether painless CP requires active endoscopic intervention or not. The United European Gastroenterology evidence-based guidelines does not recommend endoscopic treatment in painless CP patients, but the recommendation is not supported by strong clinical research evidence. European Society of Gastrointestinal Endoscopy (ESGE) Guideline proposed whether active endoscopic treatment had a protective effect on the pancreatic function of patients with painless CP is still unconfirmed. On the contrary, a small sample study consisting of 41 CP patients by Katsushi found that endoscopic treatment can delay the progression of exocrine dysfunction in CP patients.Considering these contradicting results, it is urgent to conduct a clinical study to determine the effect of endoscopic treatment on preservation of pancreatic function in patients with 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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosed with chronic pancreatitis without pain attack related with chronic pancreatitis;
  • calcified stone in the cephalic or corporeal portion of the main pancreatic duct with upstream duct dilation;
  • no ERCP or ESWL carried out before admission;

排除标准

  • suspected to have malignant tumors;
  • history of pancreatic surgery or gastrojejunostomy (Billroth II);
  • with end-stage disease;
  • pregnancy or lactation;
  • refuse to write informed consent

研究组 & 干预措施

Endoscopic group

Experimental

The patients received intravenous analgesia (flurbiprofen and remifentanil) before the ESWL (Compact Delta II; Dornier Med Tech, Wessling, Germany). After the last ESWL session, the patients are treated with following ERCP within 48h. ERCP was performed under conscious sedation with intramuscular administration of diazepam 2.5-5.0 mg and pethidine 25-50 mg. If necessary, endoscopic sphincterotomy was performed. A dilating bougie or balloon will be used to dilate the stenosis after sphincterotomy. Standard techniques (i.e., extraction basket, extraction balloon, or both) will be used for stone removal. A pancreatic duct stent for drainage and nasopancreatic catheters will be inserted for temporary drainage if necessary. Conservative treatments similar to patients in the control group were given in endoscopic group according to patients' condition.

干预措施: extracorporeal shock wave lithotripsy and endoscopic drainage of the main pancreatic duct (Procedure)

Conservative group

Other

Patients will have pancreatic enzymes (Pancreatin Enteric-coated Capsules or Oryz-Aspergillus Enzyme and Pancreatin Table) to control symptoms of exocrine pancreatic insufficiency. The recommended initial dose for adults is (25 000-40 000) IU lipase per meal (40 000 IU for meals and 20 000 IU for snacks), which can be increased until the PEI is relieved. The maximum recommended dose is (75 000-80 000) IU lipase per meal. Actions including drugs(Acarbose Tablets, Glucophage, Glimepirde Tablets) or insulin(Biosynthetic Human Insulin Injection, Tresiba or both) would also be taken for control of diabetes according to patients' glucose levels.

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

结局指标

主要结局

exocrine function of the pancreas assessed by the value of fecal elastase in μg/g

时间窗: 12 months

Pancreatic exocrine function insufficiency(PEI) is defined as fecal elastase \<200 μg/g. The result wii be divided into 4 conditions, including normal exocrine function, newly developed PEI, PEI relief, PEI persisting.

次要结局

  • endocrine function of the pancreas assessed by fasting C peptide in ug/L(12 months)
  • endocrine function of the pancreas assessed by glycosylated hemoglobin in %.(12 months)
  • life quality assessed by SF-36 questionnaire(12 months)
  • endocrine function of the pancreas assessed by fasting blood glucose in mmol/L(12 months)

研究者

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

Zhuan Liao

Clinical Professor

Changhai Hospital

研究点 (1)

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