The Prophylactic Effect of Stilamin on Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis
- Conditions
- Post-ERCP Acute Pancreatitis
- Interventions
- Drug: Stilamin+common daily treatmentOther: Common daily practice
- Registration Number
- NCT01431781
- Lead Sponsor
- Changhai Hospital
- Brief Summary
Pancreatitis are one of the most common complications of post-ERCP (Endoscopic Retrograde Cholangiopancreatography), the incidence rate is 5\&-10%, how to prevent PEP and hyperamylasemia is an important issue, somatostatin is widely used in the field of pancreas treatment. In order to explore the effects of somatostatin on prevent PEP(post-ERCP Pancreatitis), 908 subjects will be enrolled in two group in the study, one group is given common treatment, the other uses somatostatin in the base of common treatment.
- Detailed Description
A prospective, multi-center, investigator sponsored, randomized controlled trial, 15 sites join in in China, 908 subjects will be enrolled.
A descriptive analysis will be performed on primary endpoint, containing frequency of number and percentage of patients. A two proportion equality test will be conducted to explore whether incidence rates are different.
Descriptive statistics including number (N), mean, median, standard deviation, minimum and maximum, will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 908
- Males and females, age > 18 years.
- Normal amylase level before undergoing ERCP.
- Signed inform consent form and agreed to follow-up on time.
- Pregnancy or history of allergy to somatostatin.
- Renal insufficiency (Scr>177umol/L).
- Acute myocardial infarction within 3 months of the procedure.
- History of subtotal gastrectomy (Billroth II Method).
- Symptom of shock before undergoing ERCP, such as hypotension (systolic blood pressure < 90mmHg) or tachycardia (HR > 120 bpm).
- Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent .
- Patients involved in other study within 60 days.
- Patients unfitted for the study by investigators.
- All contraindications to Stilamin.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description stilamin+common daily treatment Stilamin+common daily treatment - common daily treatment Common daily practice -
- Primary Outcome Measures
Name Time Method the prophylaxis effect of Stilamin on post-ERCP pancreatitis the incidence rate of PEP at 24 h after ERCP in two groups If the serum amylase of patients elevation and 3 times higher than the normal values after ERCP 24 hours, patients also have clinical symptoms, without other acute abdominal diseases,such as gastrointestinal perforation,acute cholecystitia and acute cholangitis and etc. In this condition, it will be defined PEP(post-ERCP pancreatitis).
A descriptive analysis will be performed on primary endpoint, containing frequecency of number and percentage of patients. A two proportion equality test will be conducted to explore whether incidence rates are different.
- Secondary Outcome Measures
Name Time Method the prophylaxis effect of Stilamin in sub-groups of patient with high risk PEP occurence rate at 24 h after ERCP at high-risk patients in two groups If the serum amylase of patients elevation and 3 times higher than the normal values after ERCP 24 hours in high risk patients, who also have clinical symptoms, without other acute abdominal diseases,such as gastrointestinal perforation,acute cholecystitia and acute cholangitis and etc. In this condition, it will be defined PEP(post-ERCP pancreatitis).
Descriptive statistics will be produced for all continuous variables.Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.compare Stilamin treated group with the other group on the incidence of hyperamylasemia/adverse events. the incidence of hyperamylasemia/adverse events at 24 h after ERCP in two groups Hyperamylasemia will be defined as the serum amylase 3 times more than the upper normal values, without clinical symptoms.During the study, any unexpected medical issue will be called adverse event.
Descriptive statistics will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.
Trial Locations
- Locations (15)
Xijing Hospital
🇨🇳Xi,an, Shanxi, China
Shanghai First People Hospital
🇨🇳Shanghai, China
Changhai Hospital
🇨🇳Shanghai, China
Eastern Hepatobiliary Surgery Hospital
🇨🇳Shanghai, China
Tongji Hospital
🇨🇳Wuhan, China
Beijing Friendship Hospital
🇨🇳Beijing, China
Xinan Hospital
🇨🇳Chongqing, China
Hangzhou First People Hospital
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Wulumuqi General Hospital of Chinese PLA
🇨🇳Wulumuqi, Xinjiang, China
Fujian Province Hospital
🇨🇳Fuzhou, Fujian, China
Nanfang Hospital
🇨🇳Guangzhou, Guangdong, China
The People' Hospital of Heilongjiang Province
🇨🇳Haerbin, Heilongjiang, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, Jiangsu, China
Jiangsu Province of TCM
🇨🇳Nanjing, China