Extracorporeal Shock Wave Lithotripsy Versus Extracorporeal Shock Wave Lithotripsy Combined With Endoscopic Treatment for Painful Calcified Chronic Pancreatitis
试验速览
- 阶段
- 不适用
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Change from baseline pain score as accessed by izbichi pain score at 12 month
研究概览
简要总结
The study wants to compare ESWL alone with ESWL and endoscopic drainage of the MPD for treatment of pain in chronic pancreatitis.
详细描述
The combination mode of ESWL and ERCP is an established method of treatment of painful obstructive calcified chronic pancreatitis. However, the investigators notice that patients after ESWL alone in calcified CP is followed by spontaneous elimination of stone fragments and pain relief. Inui reported that 40% of 555 patients spontaneous eliminate stone fragments. Dumonceau found that combining systematic endoscopy with ESWL adds to the cost of patient care, without improving the outcome of the pancreatic pain.
So the investigators design such a prospective and randomized controlled trial. People diagnosed with uncomplicated painful chronic pancreatitis and calcifications obstructing the MPD will be randomly assigned to the ESWL or endoscopy group according to a table of random numbers.
ESWL will be performed in all patients using a electromagnetic lithotriptor. ESWL sessions will be repeated if necessary, until stone fragmentation is obtained. Patients in the endoscopy group will undergo endoscopy in 48 hours with possible stent insertion. In the ESWL group, if pain continues or aggravates, endoscopic drainage of the MPD will be carried out.
Follow-up will consists of telephone interview1 after treatment and clinical examination every 6 months thereafter. Data collected will include clinical presentation, ESWL, endoscopic and surgical procedures, life quality. In addition, S-MRCP will be performed 6 months after treatment. Blood glucose, insulin, stool elastase will be taken each clinical examination.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •painful chronic pancreatitis(abdominal pain attack during the preceding 12 months);
- •at least 1 calcified stone greater than 5 mm in one of its axes 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);
- •pancreatic collection greater than 2 cm in diameter at magnetic resonance or CT scan;
- •age below 18 years;
- •pregnancy or lactation;
- •refuse to write informed consent
研究组 & 干预措施
ESWL alone
Patients in this group would be treated with extracorporeal shock wave lithotripsy only. Otherwise, extra endoscopic procedures will be carried out in case of continuous and aggravated pain. Analgesics will be administrated as needed and recorded.
干预措施: extracorporeal shock wave lithotripsy (Procedure)
ESWL alone
Patients in this group would be treated with extracorporeal shock wave lithotripsy only. Otherwise, extra endoscopic procedures will be carried out in case of continuous and aggravated pain. Analgesics will be administrated as needed and recorded.
干预措施: Analgesics (Drug)
ESWL combined with ERCP
People in this group would be treated with ESWL followed be endoscopic drainage of the main pancreatic duct in 48 hours. Analgesics will be administrated as needed and recorded.
干预措施: endoscopic drainage of the main pancreatic duct (Procedure)
ESWL combined with ERCP
People in this group would be treated with ESWL followed be endoscopic drainage of the main pancreatic duct in 48 hours. Analgesics will be administrated as needed and recorded.
干预措施: Analgesics (Drug)
结局指标
主要结局
Change from baseline pain score as accessed by izbichi pain score at 12 month
时间窗: 12 months
Whether pain is relieved depends on the change of Izbicki pain score at the baseline and 12 months after the procedure(ERCP alone or ERCP combined with ERCP). Izbicki pain score is composed of 4 parts, that is frequency of pain attacks(daily counts for 100, several times a week counts for 75, several times a month counts for 50, several times a year counts for 25 and several times a year counts for 0), VAS(subjective evaluation of pain by patients from no pain which is 0 points to imaginative maximum of pain which is 100 points), analgesic medication(morphine consumption is 100, buprenorphine is 80, pethidine is 20, tramaldol is 15, metamizole is 3 and acetylsalicylacid is 1) and time of disease-related inability to work(permanet is 100, ≤1 month is 50, ≤1 week is 25 and no inability to work during the last year is 0). Each part counts for 100 points in all.
次要结局
- decompression rate of the pancreatic duct as the change of pancreatic duct diameter assessed by S-MRCP(12 months)
- exocrine function of the pancreas through determination of fecal elastase as assessed by fecal elastase kit(12 months)
- clearance of pancreatic stones(12 months)
研究者
Zhuan Liao
Deputy Director
Changhai Hospital