Post-ERCP Acute Pancreatitis
Conditions
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.
Interventions
DRUGStilamin+common daily treatment
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.
Fasted for 6h after ERCP, Fluid replacement, Gastric acid inhibition, Antiinflammatory
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactShen Zh Li, Pro.
Outcome results
None listed