The Prophylactic Effect of Stilamin on Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Multi-center, Investigator Sponsored, Randomized Controlled Trial-- The Prophylactic Effect of Stilamin on Post-ERCP Pancreatitis

Conditions
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Post-ERCP Acute Pancreatitis

Intervention / Treatment
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* Drug: Stilamin+common daily treatment
* Other: Common daily practice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females, age > 18 years. Normal amylase level before undergoing ERCP. Signed inform consent form and agreed to follow-up on time. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stilamin+common daily treatment<br> | Drug: Stilamin+common daily treatment<br>* dose:250 micrograms bolus intravenous in 3 minutes when ERCP starts and continuous infusion for 11 hours after ERCP. Common daily treatment: fasted for 6h after ERCP, Fluid replacement, Gastric acid inhibition, Antiinflammatory.<br>* Other names: Somatostatin:Stilamin;|
| Active Comparator: common daily treatment<br> | Other: Common daily practice<br>* Fasted for 6h after ERCP, Fluid replacement, Gastric acid inhibition, Antiinflammatory<br>* Other names: Antiinflammatory;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the prophylaxis effect of Stilamin on post-ERCP pancreatitis | 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. | the incidence rate of PEP at 24 h after ERCP in two groups | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the prophylaxis effect of Stilamin in sub-groups of patient with high risk | 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. | PEP occurence rate at 24 h after ERCP at high-risk patients in two groups | 
| compare Stilamin treated group with the other group on the incidence of hyperamylasemia/adverse events. | 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. | the incidence of hyperamylasemia/adverse events at 24 h after ERCP in two groups |